A Study of CCX140-B in Subjects With FSGS | NCT03536754 | Trialant
NCT03536754
Sponsor
Amgen
Status
Completed
Last Update Posted
Mar 13, 2025Actual
Enrollment
46Actual
Phase
Phase 2
Conditions
FSGS
Focal Segmental Glomerulosclerosis
Glomerulosclerosis
Interventions
Placebo
CCX140-B
CCX140-B
CCX140-B
Countries
United States
Australia
Canada
France
Italy
New Zealand
Poland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03536754
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CL011_140
Secondary IDs
ID
Type
Description
Link
LUMINA-1
Other Identifier
Chemocentryx
NCT03536754
Other Identifier
US NCT number
134007
Other Identifier
IND
Brief Title
A Study of CCX140-B in Subjects With FSGS
Official Title
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
May 17, 2018Actual
Primary Completion Date
Feb 19, 2020Actual
Completion Date
Feb 19, 2020Actual
First Submitted Date
Mar 28, 2018
First Submission Date that Met QC Criteria
May 23, 2018
First Posted Date
May 25, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 17, 2023
Results First Submitted that Met QC Criteria
Dec 4, 2023
Results First Posted Date
Dec 5, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 4, 2025
Last Update Posted Date
Mar 13, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia
Detailed Description
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) to be conducted in the North America, Europe and Australia. The aim of this study is to evaluate the effect of treatment with CCX140-B, a selective antagonist of C-C chemokine receptor type 2 in subjects with focal segmental glomerulosclerosis on urinary protein excretion as assessed by changes in urine protein to creatinine ratio (UPCR).
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Conditions Module
Conditions
FSGS
Focal Segmental Glomerulosclerosis
Glomerulosclerosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
46Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A
Placebo Comparator
Placebo (N=10)
Other: Placebo
Group B
Experimental
CCX140-B 5 mg once daily (N=10)
Drug: CCX140-B
Group C
Experimental
CCX140-B 10 mg twice daily (N=10)
Drug: CCX140-B
Group D
Experimental
CCX140-B 15 mg twice daily (N=10)
Drug: CCX140-B
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Other
Three placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks)
Group A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in UPCR at Week 12
Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat
Baseline to Week 12
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)
TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.
Baseline to Week 12, and Week 12 to Week 24
Change From Baseline in Activated Partial Thromboplastin Time
Normal Range: 23.9 - 40.0
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Alanine Aminotransferase
Normal Range: 6 - 41 U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Alkaline Phosphatase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Amylase
Normal range: 22-123 U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Aspartate Aminotransferase
Normal range : 9-34 U/L
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24
Change from baseline in eGFR calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; MDRD: Modification of Diet in Renal Disease Open label extension covers Baseline to Week 12 and Baseline to Week 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged 18-75
UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening
Diagnosis of FSGS based on renal biopsy or high risk genetic variant
Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity.
Clinical stable blood pressure not to exceed 145/95 mmHg
RAAS blockers must be stable for at least 4 weeks prior to screening and projected to remain stable through week 12, unless adjustments are required for management of hypertension.
Immunosuppressive or immunomodulatory therapy must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12
Glucocorticoids must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12.
Both genders of childbearing potential must agree to use adequate contraception during and for at least 3 months after the last dose of study drug.
Subjects must be willing and able to give written Informed Consent and to comply with protocol requirements.
Subjects must be judged to be otherwise fit for the study by the Investigator. -
Exclusion Criteria:
Pregnant or nursing
History of organ transplantation
On an organ transplant waiting list or anticipated organ transplant within 6 months of screening
Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range
Plasmapheresis within 12 weeks of screening
BMI ≥40
Participation in any clinical study of an investigational product within 12 weeks or 5 half-lives of screening
Currently on dialysis or likely to require dialysis during the blinded treatment phase of the study.
History or presence of any form of cancer within 5 years of screening except excised basal cell or squamous cell carcinoma or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or completed resected without evidence or recurrence.
Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test
Renal disease associated with disorders other than FSGS that is active or has significant risk of progressing during the course of the study.
Disorders that are associated with FSGS lesions.
Evidence of tuberculosis.
Evidence of hepatic disease with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin)
Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/µL) at baseline.
QTcF greater than 450 msec.
History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal.
History of gastrointestinal conditions that may interfere with study medication compliance.
Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide).
History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded.
History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening.
Subjects taking lithium or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e. occasional NSAIDS for pain or fever is discouraged, but is not excluded).
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Eighty-four (84) patients were screened. Screen failure occurred in 38 (45.2%) subjects due to not meeting inclusion or exclusion criteria (35 [41.7%] subjects) and other reasons (3 [3.6%] subjects).
Recruitment Details
The recruitment took place in Australia, Canada, France, Italy, New Zealand, Poland, United Kingdom, and in the United States. The target was to enroll 40 male or female subjects. The first patient was enrolled on 17 May 2018. A total of 84 subjects were screened; 38 subjects failed screening and 46 subjects were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo: Placebo
FG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
Periods
Title
Milestones
Reasons Not Completed
Double Blind Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 29, 2018
Aug 17, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Randomized, placebo-controlled, Phase 2
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Double-blind
Who Masked
ParticipantCare ProviderInvestigator
CCX140-B Placebo
CCX140-B
Drug
One 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.
Group B
Group B
CCX140-B
Drug
Two 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days.
Group C
Group C
CCX140-B
Drug
Three 5 mg CCX140-B tablets, taken BID; per os, for 84 days.
Group D
Group D
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Bicarbonate
Normal range: 21-33 mmol/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Bilirubin
Normal range: 0.1-1.10 mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma C Reactive Protein
Normal range: 0.0-3.0 mg/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Calcium
Normal range: 8.5-10.5 mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Chloride
Normal range: 95-110 mmol/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Cholesterol
Normal range: 100-200 mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Creatine Kinase
Normal range: 23-210 U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Creatinine
Normal range: 0.62-1.44 mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Cystatin C
Normal range: 0.53-0.95 mg/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Direct Bilirubin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Glucose
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma HDL Cholesterol
HDL -High-density lipoprotein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Indirect Bilirubin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma LDL Cholesterol
LDL - Low-density lipoprotein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lactate Dehydrogenase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Pancreatic Lipase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Magnesium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Phosphate
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Potassium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Protein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Intl. Normalised Ratio
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Time
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Sodium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Triglycerides
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urate
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urea Nitrogen
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration
HGB - Hemoglobin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hematocrit
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hemoglobin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Monocytes/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Platelets
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Reticulocytes/Erythrocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Albumin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Creatinine
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Protein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24
1. Proportion of subjects achieving complete renal remission by the following definition at Weeks 12 and 24 o Reduction in UPCR to <0.3 g/g o Serum albumin within normal range (for subjects with abnormal serum creatinine levels at baseline, return to normal levels for that age group; for subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels) 2. Proportion of subjects achieving partial remission defined as UPCR reduction of ≥50% from baseline and UPCR <3.5 g/g (definition 1), assessed at Weeks 12 and 24 3. Proportion of subjects achieving partial remission defined Decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in proteinuria from baseline (definition 2), assessed at Weeks 12 and 24
Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension
Torrance
California
90502
United States
Northwest Louisiana Nephrology
Shreveport
Louisiana
71101
United States
MGH
Boston
Massachusetts
02114
United States
University of Minnesota
Minneapolis
Minnesota
55414
United States
East Carolina University
Greenville
North Carolina
27834
United States
Rhode Island Hospital
Providence
Rhode Island
02903
United States
University of Texas Health Sciences Center
Houston
Texas
77030
United States
Utah Kidney Research Institute
Salt Lake City
Utah
84115
United States
Monash Medical Centre
Clayton
Victoria
3168
Australia
Austin Health
Heidelberg
Victoria
3084
Australia
Royal Melbourne Hospital
Parkville
Australia
St. Josephs Healthcare - Hamilton
Hamilton
Ontario
L8N4A6
Canada
Sunnybrook Health Sciences Centre (Odette Cancer Center)
Toronto
Ontario
M4G 3E8
Canada
Toronto General Hospital
Toronto
Ontario
M5G2C4
Canada
CISSS de la Monteregie-Centre - Hopital Charles LeMoyne
Greenfield Park
Quebec
J4V2H1
Canada
CHU Bordeaux- Hospital Pellegrin
Bordeaux
33076
France
CHU Henri Mondor
Créteil
94010
France
CHU de Grenoble
Grenoble
38043
France
APHM - Hopital de la Conception
Marseille
13385
France
Hopitaux Prives de Metz
Metz
57045
France
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo
24127
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova
16132
Italy
Presidio Ospedaliero di Montichiari-A.O. Spedali Civili di Brescia
Montichiari
25018
Italy
Fondazione S. Maugeri IRCCS
Pavia
27100
Italy
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
Rome
00168
Italy
North Shore Hospital
Takapuna
Auckland
0622
New Zealand
Taranaki Base Hospital
New Plymouth
4310
New Zealand
Uniwersytecki Szpital Kliniczny w Bialymstoku - II Klinika Nefrologii z Oddzialem Leczenia Nadcisnienia Tetniczego i Pododdzialem Dializoterapii
Uniwersytecki Szpital Kliniczny Klinika Nefrologii i Medycyny Transplantacyjnej
Wroclaw
50-556
Poland
Cambridge University - Addenbrooke's Hospital
Cambridge
CB2 0OQ
United Kingdom
University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom
Salford Royal NHS Foundation Trust Manchester
Salford
M6 8HD
United Kingdom
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
FG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
FG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
FG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
FG00012 subjects
FG00111 subjects
FG00212 subjects
FG00311 subjects
FG0040 subjects
COMPLETED
FG00012 subjects
FG00111 subjects
FG00211 subjects
FG00311 subjects
FG0040 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Open Label Extension
Type
Comment
Milestone Data
STARTED
FG0000 subjects46 subjects were randomised in Period A. Only 43 subjects entered the Open-Label Extension.
FG0010 subjects46 subjects were randomised in Period A. Only 43 subjects entered the Open-Label Extension.
FG0020 subjects46 subjects were randomised in Period A. Only 43 subjects entered the Open-Label Extension.
FG0030 subjects46 subjects were randomised in Period A. Only 43 subjects entered the Open-Label Extension.
FG00443 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo control
BG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
BG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
BG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00111
BG00212
BG00311
BG00446
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Age at Screening
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046.3± 12.50
BG00141.7± 12.70
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
UPCR at screening
UPCR (Urine protein g:creatinine g) Urine protein:creatinine ratio (g protein/g creatinine) ≥3.5 Units (g/dL)
Count of Participants
Participants
Title
Denominators
Categories
UPCR ≥ 3.5 at screening
Title
Measurements
BG0003
BG0012
UPCR at baseline
UPCR (Urine protein g:creatinine g)
Number
g/dL
Title
Denominators
Categories
UPCR ≥ 3.5 at baseline
Title
Measurements
BG0001
BG0011
BG002
Concomitant use of ACE inhibitor or ARB or aldosterone antagonists
Baseline urine MCP-1 creatinine ratio MCP-1: monocyte chemoattractant protein 1
Mean
Standard Deviation
g protein/g creatinine
Title
Denominators
Categories
Title
Measurements
BG000453.74± 438.384
BG001576.41± 470.089
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in UPCR at Week 12
Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat
Posted
Least Squares Mean
90% Confidence Interval
g protein/g creatinine
Baseline to Week 12
ID
Title
Description
OG000
Placebo
Placebo control
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
Units
Counts
Participants
OG00012
OG00111
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.83(0.69 to 0.99)
OG0011.02(0.84 to 1.23)
OG0021.12(0.93 to 1.35)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed effects model for repeated measure
0.1924
≤ 0.1924
LSM Ratio
1.23
Standard Error of the Mean
1.171
2-Sided
90
0.95
1.6
Superiority
OG000
OG002
Mixed effects model for repeated measure
Primary
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)
TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.
Posted
Count of Participants
Participants
Baseline to Week 12, and Week 12 to Week 24
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Primary
Change From Baseline in Activated Partial Thromboplastin Time
Normal Range: 23.9 - 40.0
Data is not available for all participants.
Posted
Mean
Standard Deviation
second
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Primary
Change From Baseline in Plasma Alanine Aminotransferase
Normal Range: 6 - 41 U/L
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Alkaline Phosphatase
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Amylase
Normal range: 22-123 U/L
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Aspartate Aminotransferase
Normal range : 9-34 U/L
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Bicarbonate
Normal range: 21-33 mmol/L
Posted
Mean
Standard Deviation
mmol/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Bilirubin
Normal range: 0.1-1.10 mg/dL
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma C Reactive Protein
Normal range: 0.0-3.0 mg/L
Posted
Mean
Standard Deviation
mg/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Calcium
Normal range: 8.5-10.5 mg/dL
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Chloride
Normal range: 95-110 mmol/L
Posted
Mean
Standard Deviation
mmol/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Cholesterol
Normal range: 100-200 mg/dL
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Creatine Kinase
Normal range: 23-210 U/L
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Creatinine
Normal range: 0.62-1.44 mg/dL
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Cystatin C
Normal range: 0.53-0.95 mg/L
Posted
Mean
Standard Deviation
mg/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Direct Bilirubin
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Glucose
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma HDL Cholesterol
HDL -High-density lipoprotein
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Indirect Bilirubin
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma LDL Cholesterol
LDL - Low-density lipoprotein
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Lactate Dehydrogenase
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Pancreatic Lipase
Posted
Mean
Standard Deviation
U/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Magnesium
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Phosphate
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Potassium
Posted
Mean
Standard Deviation
mmol/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Protein
Posted
Mean
Standard Deviation
g/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Prothrombin Intl. Normalised Ratio
Posted
Mean
Standard Deviation
Prothombin intl. normalised ratio
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Prothrombin Time
Posted
Mean
Standard Deviation
second
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Sodium
Posted
Mean
Standard Deviation
mmol/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Triglycerides
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Urate
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Plasma Urea Nitrogen
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Basophils
Posted
Mean
Standard Deviation
cells x 10^9/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Basophils/Leukocytes
Posted
Mean
Standard Deviation
percentage of basophils in leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Eosinophils
Posted
Mean
Standard Deviation
cells x 10^9/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Eosinophils/Leukocytes
Posted
Mean
Standard Deviation
percentage of Eosinophils in Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration
HGB - Hemoglobin
Posted
Mean
Standard Deviation
g/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Posted
Mean
Standard Deviation
picogram(s)
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Posted
Mean
Standard Deviation
fL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Erythrocytes
Posted
Mean
Standard Deviation
cells x 10^12/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Hematocrit
Posted
Mean
Standard Deviation
percentage of red blood cells in blood
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Hemoglobin
Posted
Mean
Standard Deviation
g/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Leukocytes
Posted
Mean
Standard Deviation
cells x 10^3/microlitre
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Lymphocytes
Posted
Mean
Standard Deviation
cells x 10^3/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Lymphocytes/Leukocytes
Posted
Mean
Standard Deviation
percentage of lymphocytes in leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Monocytes/Leukocytes
Posted
Mean
Standard Deviation
percentage of monocytes in leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Neutrophils
Posted
Mean
Standard Deviation
cells x 10^3/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Neutrophils/Leukocytes
Posted
Mean
Standard Deviation
percentage of neutrophils in leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Platelets
Posted
Mean
Standard Deviation
cells x 10^9/L
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Reticulocytes/Erythrocytes
Posted
Mean
Standard Deviation
percentage of reticulocytes/erythrocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Urine Albumin
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Urine Creatinine
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Primary
Change From Baseline in Urine Protein
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Secondary
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24
Change from baseline in eGFR calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; MDRD: Modification of Diet in Renal Disease Open label extension covers Baseline to Week 12 and Baseline to Week 24
Posted
Mean
Standard Deviation
mL/min/1.73 m^2
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
Secondary
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24
1. Proportion of subjects achieving complete renal remission by the following definition at Weeks 12 and 24 o Reduction in UPCR to <0.3 g/g o Serum albumin within normal range (for subjects with abnormal serum creatinine levels at baseline, return to normal levels for that age group; for subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels) 2. Proportion of subjects achieving partial remission defined as UPCR reduction of ≥50% from baseline and UPCR <3.5 g/g (definition 1), assessed at Weeks 12 and 24 3. Proportion of subjects achieving partial remission defined Decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in proteinuria from baseline (definition 2), assessed at Weeks 12 and 24
Posted
Count of Participants
Participants
Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension
ID
Title
Description
OG000
Placebo
Placebo: Placebo
OG001
CCX140-B 5 mg Once Daily
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG002
CCX140-B 10 mg Twice Daily
CCX140-B 10 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
Time Frame
From Baseline to Week 24
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo control
0
11
0
11
7
11
EG001
CCX140-B 5 mg
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
0
11
0
11
8
11
EG002
CCX140-B 10 mg
CCX140-B 10 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
0
12
0
12
10
12
EG003
CCX140-B 15 mg
CCX140-B 15 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
0
11
0
11
8
11
EG004
Placebo Open Label
Placebo control
For Period B of trial
0
11
0
11
7
11
EG005
CCX140-B 5mg Open Label
CCX140-B 5 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial
0
11
0
11
6
11
EG006
CCX140-B 10mg Open Label
CCX140-B 10 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial
0
11
1
11
6
11
EG007
CCX140-B 15mg Open Label
CCX140-B 15 mg once daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2 For Period B of trial
0
10
0
10
5
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute kidney injury
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected11 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected11 at risk
EG0070 events0 affected10 at risk
Dermo-hypodermitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected11 at risk
EG0041 events1 affected11 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected11 at risk
EG0070 events0 affected10 at risk
Bronchitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Dermo-hypodermitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Herpes dermatitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Influenza
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0015 events4 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Fatigue
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events2 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Oedema
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Asthenia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Chills
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Influenza like illness
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0002 events2 affected11 at risk
EG0012 events2 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0004 events2 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events2 affected11 at risk
EG0022 events2 affected12 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Infrequent bowel movements
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 events2 affected11 at risk
EG0012 events1 affected11 at risk
EG0026 events1 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected11 at risk
EG0022 events1 affected12 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Migraine
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Blood potassium increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Grip strength decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Immunosuppressant drug level increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Lipase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Weight increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected11 at risk
EG0023 events1 affected12 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Cystatin C increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Menstruation delayed
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Hot flush
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected12 at risk
EG003
Blepharospasm
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected12 at risk
EG003
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C585356
CCX140-B
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
42 subjects
1 subjects
0 subjects
FG0041 subjects
0
BG0040
Between 18 and 65 years
BG00012
BG00111
BG00211
BG00310
BG00444
>=65 years
BG0000
BG0010
BG0021
BG0031
BG0042
37.9
± 15.51
BG00343.4± 13.26
BG00442.3± 13.47
5
BG0033
BG00416
Male
BG0008
BG0017
BG0027
BG0038
BG00430
0
BG0030
BG0040
Asian
BG0000
BG0011
BG0020
BG0030
BG0041
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
Black or African American
BG0001
BG0010
BG0021
BG0031
BG0043
White
BG00011
BG00110
BG00211
BG0039
BG00441
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0041
0
BG0030
BG0040
Asian
BG0000
BG0011
BG0020
BG0030
BG0041
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
Black or African American
BG0001
BG0010
BG0021
BG0031
BG0043
White
BG00011
BG00110
BG00211
BG0039
BG00441
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0041
BG002
3
BG0033
BG00411
UPCR < 3.5 at screening
Title
Measurements
BG0009
BG0019
BG0029
BG0038
BG00435
3
BG0034
BG0049
UPCR < 3.5 at baseline
Title
Measurements
BG00011
BG00110
BG0029
BG0037
BG00437
BG002
11
BG00310
BG00443
No
Title
Measurements
BG0000
BG0011
BG0021
BG0031
BG0043
6
BG0036
BG00425
No
Title
Measurements
BG0005
BG0015
BG0026
BG0035
BG00421
4
BG0035
BG00419
No
Title
Measurements
BG0006
BG0017
BG0028
BG0036
BG00427
3
BG0033
BG00412
No
Title
Measurements
BG00010
BG0017
BG0029
BG0038
BG00434
3
BG0031
BG0046
No
Title
Measurements
BG00011
BG00110
BG0029
BG00310
BG00440
2.86
± 2.008
BG0033.12± 2.504
BG0042.54± 1.773
56.18
± 28.927
BG00254.67± 15.622
BG00361.36± 32.265
BG00461.35± 29.163
BG002504.02± 388.569
BG003430.66± 325.651
BG004490.67± 399.559
11
0.87
(0.72 to 1.05)
0.0612
≤ 0.0612
LSM Ratio
1.35
Standard Error of the Mean
1.172
2-Sided
90
1.04
1.76
Superiority
OG000
OG003
Mixed effects model for repeated measure
0.7653
≤ 0.7653
LSM Ratio
1.05
Standard Error of the Mean
1.169
2-Sided
90
0.81
1.36
Superiority
OG000
OG001
OG002
OG003
Mixed effects model for repeated measure
0.1537
≤ 0.1537
LSM Ratio
1.2
Standard Error of the Mean
1.136
2-Sided
90
0.97
1.48
Superiority
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Units
Counts
Participants
OG00012
OG00111
OG00212
OG00311
OG00443
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00010
OG0016
OG0028
OG0037
OG00424
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAEs leading to study withdrawal
Title
Measurements
OG0000
OG0010
OG0021
OG003
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Units
Counts
Participants
OG00012
OG00110
OG00210
OG00310
OG00440
Title
Denominators
Categories
Week 12
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00310
ParticipantsOG00440
Title
Measurements
OG0002.40± 4.259
OG0012.05± 4.396
OG0022.36± 2.614
OG003
Week 24
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.5± 2.70
OG0010.8± 5.22
OG0020.3± 3.29
OG003-1.8± 2.95
OG0040.0± 3.65
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG00010.2± 7.08
OG001-1.0± 11.59
OG0020.7± 15.86
OG003-1.9± 9.45
OG0042.3± 12.16
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0003.1± 16.11
OG0018.9± 18.30
OG0025.0± 24.56
OG0033.9± 23.19
OG0045.2± 20.09
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG00018.3± 6.17
OG001-0.4± 4.60
OG002-3.5± 7.71
OG003-3.2± 3.07
OG004-1.7± 5.25
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.5± 3.45
OG001-0.4± 3.24
OG0020.9± 3.59
OG003-0.6± 2.83
OG0040.1± 3.24
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.044± 0.1985
OG001-0.006± 0.2796
OG0020.160± 0.2381
OG003-0.012± 0.1519
OG0040.050± 0.2263
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0001.200± 3.1597
OG0012.144± 8.5528
OG002-1.000± 4.6448
OG003-1.444± 3.8014
OG0040.260± 5.4276
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.18± 0.387
OG0010.20± 0.427
OG0020.17± 0.498
OG003-0.01± 0.454
OG0040.14± 0.434
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 2.70
OG0010.9± 1.79
OG002-0.8± 3.31
OG0033.2± 2.33
OG0040.6± 2.97
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG000-2.7± 31.11
OG001-2.0± 27.67
OG00218.9± 48.17
OG003-43.0± 64.17
OG004-5.6± 47.99
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG00021.2± 39.65
OG00118.1± 59.20
OG002-19.5± 89.93
OG00314.2± 206.95
OG00411.9± 89.15
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.060± 0.1437
OG0010.033± 0.2461
OG0020.115± 0.2186
OG0030.147± 0.3790
OG0040.161± 0.3926
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.114± 0.1838
OG0010.104± 0.1074
OG0020.093± 0.2896
OG0030.018± 0.2198
OG0040.087± 0.2436
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.011± 0.0396
OG0010.008± 0.0316
OG0020.005± 0.0497
OG003-0.005± 0.0254
OG0040.004± 0.0373
Units
Counts
Participants
OG00011
OG00111
OG00211
OG00311
OG00440
Title
Denominators
Categories
Title
Measurements
OG000-5.3± 15.11
OG0011.1± 10.58
OG0021.5± 16.91
OG003-6.2± 14.07
OG004-0.9± 14.27
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.8± 5.75
OG001-2.3± 12.95
OG0022.1± 20.41
OG0032.4± 9.65
OG0040.7± 9.39
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.043± 0.1033
OG001-0.009± 0.0919
OG0020.054± 0.2866
OG003-0.043± 0.1572
OG0040.046± 0.1947
Units
Counts
Participants
OG00010
OG00111
OG00210
OG00310
OG00438
Title
Denominators
Categories
Title
Measurements
OG00012.2± 19.97
OG001-2.8± 11.36
OG0028.0± 24.86
OG003-8.9± 37.78
OG004-5.0± 37.61
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG000-10.2± 25.67
OG001-26.4± 69.73
OG002-14.5± 26.09
OG0035.1± 27.15
OG004-12.0± 41.83
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0003.6± 9.71
OG0018.1± 24.14
OG002-5.2± 9.81
OG00324.5± 51.50
OG0049.0± 50.27
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.10± 0.148
OG0010.02± 0.140
OG002-0.02± 0.240
OG0030.09± 0.321
OG0040.01± 0.199
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.33± 0.609
OG0010.16± 0.423
OG0020.15± 0.596
OG0030.04± 0.803
OG0040.04± 0.580
Units
Counts
Participants
OG00011
OG00111
OG00211
OG00310
OG00438
Title
Denominators
Categories
Title
Measurements
OG0000.09± 0.327
OG0010.12± 0.232
OG002-0.09± 0.305
OG0030.23± 0.789
OG0040.00± 0.514
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.17± 0.320
OG0010.05± 0.305
OG002-0.11± 0.575
OG003-0.09± 0.396
OG0040.00± 0.515
Units
Counts
Participants
OG00012
OG00110
OG00210
OG00310
OG00440
Title
Denominators
Categories
Title
Measurements
OG0000.03± 0.210
OG0010.01± 0.160
OG0020.10± 0.141
OG0030.01± 0.088
OG0040.08± 0.387
Units
Counts
Participants
OG00012
OG00110
OG00210
OG00310
OG00440
Title
Denominators
Categories
Title
Measurements
OG0000.48± 1.566
OG0010.07± 1.561
OG0020.69± 1.268
OG0030.33± 0.736
OG0040.78± 3.445
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.0± 2.22
OG0011.8± 3.89
OG0020.9± 3.59
OG0032.5± 5.05
OG0041.0± 3.46
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG00016.6± 123.84
OG0015.7± 51.48
OG002-16.5± 25.80
OG003-23.2± 123.79
OG004-2.6± 80.08
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0000.51± 0.485
OG0010.04± 1.107
OG002-0.28± 0.877
OG003-0.08± 0.926
OG004-0.05± 1.040
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00441
Title
Denominators
Categories
Title
Measurements
OG0002.8± 3.65
OG001-2.6± 4.18
OG0023.6± 5.95
OG0031.1± 11.42
OG0042.3± 6.15
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG0000.02± 0.058
OG0010.03± 0.047
OG0020.02± 0.60
OG003-0.03± 0.048
OG0040.02± 0.063
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG0000.08± 0.389
OG001-0.01± 0.459
OG0020.18± 0.547
OG003-0.13± 0.419
OG0040.16± 0.433
Units
Counts
Participants
OG00012
OG00111
OG00212
OG00311
OG00439
Title
Denominators
Categories
Title
Measurements
OG0000.01± 0.108
OG0010.01± 0.122
OG0020.00± 0.184
OG0030.01± 0.099
OG0040.03± 0.162
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG0000.32± 1.375
OG0010.09± 0.984
OG002-0.02± 2.245
OG0030.33± 1.430
OG0040.27± 1.922
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.20± 0.603
OG001-0.18± 0.778
OG002-0.24± 0.439
OG003-0.16± 0.556
OG004-0.28± 0.891
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 0.58
OG001-0.3± 0.47
OG002-0.5± 0.82
OG0030.0± 0.82
OG004-0.1± 0.80
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.21± 1.472
OG001-0.02± 2.093
OG002-0.33± 1.251
OG0030.03± 1.931
OG0040.44± 1.801
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.004± 0.2946
OG0010.055± 0.2211
OG0020.010± 0.2326
OG003-0.55± 0.1761
OG004-0.003± 0.2968
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 2.34
OG0010.5± 2.11
OG002-0.1± 2.26
OG003-0.8± 1.55
OG0040.2± 2.61
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.12± 0.802
OG0010.13± 0.588
OG002-0.10± 0.784
OG003-0.25± 0.488
OG004-0.07± 0.923
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.98± 1.915
OG0010.45± 1.012
OG0020.37± 1.819
OG003-0.09± 1.928
OG004-0.09± 1.711
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.080± 0.2152
OG0010.122± 0.3541
OG0020.099± 0.4865
OG0030.194± 0.9257
OG0040.161± 0.4165
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG0002.51± 5.052
OG0010.06± 6.287
OG002-0.99± 8.132
OG0031.52± 7.013
OG0042.61± 7.099
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG0001.38± 1.641
OG0010.25± 2.056
OG0020.99± 3.022
OG0030.56± 1.532
OG004-0.21± 2.262
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.954± 1.6290
OG0010.255± 1.1041
OG0020.137± 1.6023
OG003-0.289± 1.4171
OG004-0.281± 1.5104
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-4.28± 5.941
OG001-0.39± 6.548
OG002-0.16± 8.247
OG003-2.28± 7.230
OG004-2.84± 7.830
Units
Counts
Participants
OG00012
OG00110
OG00211
OG00310
OG00443
Title
Denominators
Categories
Title
Measurements
OG0005.2± 31.68
OG00126.2± 30.10
OG0024.8± 28.72
OG0030.9± 27.65
OG00419.1± 54.30
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00310
OG00439
Title
Denominators
Categories
Title
Measurements
OG000-0.08± 0.626
OG001-0.11± 0.554
OG002-0.30± 0.615
OG003-0.12± 0.290
OG004-0.14± 0.536
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00442
Title
Denominators
Categories
Title
Measurements
OG0001.117± 118.7664
OG001-19.044± 119.7149
OG002-8.455± 53.9332
OG003-35.964± 178.9164
OG004-28.433± 107.8847
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00442
Title
Denominators
Categories
Title
Measurements
OG00010.65± 35.931
OG001-11.67± 33.432
OG002-15.37± 30.920
OG00325.30± 84.654
OG004-6.96± 31.530
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00442
Title
Denominators
Categories
Title
Measurements
OG000-19.3± 139.96
OG001-8.9± 134.17
OG002-9.0± 80.51
OG003-80.6± 230.57
OG004-35.1± 144.93
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.
Units
Counts
Participants
OG00012
OG00111
OG00211
OG00311
OG00443
Title
Denominators
Categories
CKD-EPI Cystatin C equation Week 12
Title
Measurements
OG000-4.9± 11.74
OG001-3.1± 3.91
OG002-1.6± 8.61
OG0030.2± 9.51
OG004-1.7± 9.49
CKD-EPI Cystatin C equation Week 24
Title
Measurements
OG000-0.8± 6.63
OG001-3.2± 10.40
OG002-1.3± 9.69
OG003
CKD-EPI Creatinine equation Week 12
Title
Measurements
OG000-3.0± 6.47
OG001-4.2± 11.50
OG002-3.9± 5.74
OG003
CKD-EPI Creatinine equation Week 24
Title
Measurements
OG000-3.1± 5.74
OG001-8.2± 9.89
OG002-5.3± 10.59
OG003
CKD-EPI Creatinine-Cystatin C equation Week 12
Title
Measurements
OG000-5.3± 8.92
OG001-3.5± 5.61
OG002-2.6± 6.53
OG003
CKD-EPI Creatinine-Cystatin C equation Week 24
Title
Measurements
OG000-2.4± 5.24
OG001-5.5± 9.20
OG002-3.2± 9.18
OG003
MDRD Creatinine equation Week 12
Title
Measurements
OG000-4.7± 10.82
OG001-5.1± 13.75
OG002-4.6± 6.23
OG003
MDRD Creatinine equation Week 24
Title
Measurements
OG000-4.5± 11.12
OG001-8.8± 12.85
OG002-5.9± 10.05
OG003
OG003
CCX140-B 15 mg Twice Daily
CCX140-B 15 mg twice daily
CCX140-B: CCX140-B is an orally administered selective antagonist of CCR2
OG004
Open-label Extension
Following the 12-week Blinded Treatment Period, all subjects who remained eligible took open-label CCX140-B for an additional 12 weeks (84 consecutive days) at the highest tolerated dose under evaluation, which was determined to be 15 mg BID.