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| ID | Type | Description | Link |
|---|---|---|---|
| LUMINA-2 | Other Identifier | Chemocentryx |
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Program not advancing
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An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. The aim of this study is to explore the effect of CCX140-B, a selective antagonist of C-C chemokine receptor type 2, on proteinuria in subjects with FSGS.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential | Experimental | All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCX140-B | Drug | Orally administered tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% | Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment | Partial and complete remission were defined as follows: Partial remission (included all of the following):
Complete remission (included all of the following):
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | United States | ||
| Northwest Louisiana Nephrology |
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| ID | Title | Description |
|---|---|---|
| FG000 | CCX140-B | Drug: CCX140-B, orally administered tablet All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CCX140-B | CCX140-B is an orally administered tablet All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% | Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12. | Posted | Count of Participants | Participants | Baseline to week 12 |
|
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CCX140-B | CCX140-B is an orally administered tablet. All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amylase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
The CL012_140 study was terminated early due to lack of efficacy in another study, CL011_140, investigating the use of CCX140-B.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | ChemoCentryx | 650-210-2900 | clinicaltrials@chemocentryx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2018 | Aug 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2020 | Aug 10, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C585356 | CCX140-B |
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Open-Label, Intra-Subject, Dose Escalation
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| Baseline to week 12 |
| Proportion of Subjects With Achievement of Complete Remission During the Treatment Period | Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels. | Baseline to week 52 |
| Time Taken of Subjects to Achieve Complete Remission During the Treatment Period | Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels. | Baseline to week 52 |
| Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time | Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time. | Baseline to week 12 and week 52 |
| Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period | Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was <3.5 g/g. | Baseline to week 52 |
| Time to Rescue Therapy | Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis) | Baseline to week 52 |
| Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time | eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration | Baseline to Week 12 and Week 52 |
| Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time | CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate | Baseline to Week 12 and Week 52 |
| Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time | CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate; | Baseline to Week 12 and Week 52 |
| Mean Change From Baseline for the MDRD Creatinine Equation Over Time | MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52 | Baseline to Week 12 and Week 52 |
| Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2 | Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health). | Baseline to Week 52 |
| Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial | Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine. | Baseline to Week 12 and Week 52 |
| Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial | Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial | Baseline to Day 57 |
| Shreveport |
| Louisiana |
| 71101 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Utah Kidney Research Institute | Salt Lake City | Utah | 84115 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Age at diagnosis of FSGS (years) | FSGS= Focal segmental glomerulosclerosis | Mean | Standard Deviation | years |
|
| Duration of FSGS (months) | Duration of Focal segmental glomerulosclerosis (FSGS) was calculated from the time of first diagnosis based on renal biopsy. | Mean | Standard Deviation | months |
|
| Baseline UPCR - morning void | UPCR= Urine protein:creatinine ratio | Mean | Standard Deviation | g protein/ g creatinine |
|
| Baseline UPCR - 24-hour | Mean | Standard Deviation | g protein/ g creatinine |
|
| Baseline UACR - morning void | UACR= Urinary albumin:creatinine ratio | Mean | Standard Deviation | g protein/ g creatinine |
|
| Baseline UACR - 24-hour | Mean | Standard Deviation | g protein/ g creatinine |
|
| Concomitant use of glucocorticoids and/or immunosuppressive medications | Count of Participants | Participants |
|
| Concomitant use of ACE inhibitor or ARB | ACE= Angiotensin-converting enzyme, ARB= Angiotensin receptor blocker | Count of Participants | Participants |
|
| All calcineurin inhibitors combined | Includes cyclosporin or tacrolimus | Count of Participants | Participants |
|
| Concomitant use of rituximab or other anti-CD20 | Count of Participants | Participants |
|
| Baseline eGFR (CKD-EPI Creatinine-Cystatin C) | eGFR= Estimated glomerular filtration rate, CKD-EPI= Chronic Kidney Disease Epidemiology Collaboration | Mean | Standard Deviation | mL/min/1.73m² |
|
| Baseline eGFR (MDRD Creatinine) | MDRD= Modification of Diet in Renal Disease | Mean | Standard Deviation | mL/min/1.73m² |
|
| Podocyte effacement | Based on electron microscopy | Count of Participants | Participants |
|
| Glomeruli showing segmental lesions | Count of Participants | Participants |
|
|
|
| Secondary | Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment | Partial and complete remission were defined as follows: Partial remission (included all of the following):
Complete remission (included all of the following):
| Posted | Count of Participants | Participants | Baseline to week 12 |
|
|
|
| Secondary | Proportion of Subjects With Achievement of Complete Remission During the Treatment Period | Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels. | Posted | Count of Participants | Participants | Baseline to week 52 |
|
|
|
| Secondary | Time Taken of Subjects to Achieve Complete Remission During the Treatment Period | Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels. | Posted | Number | days | Baseline to week 52 |
|
|
|
| Secondary | Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time | Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time. | Data was not available for all patients at each timepoint | Posted | Mean | Standard Deviation | g protein/g creatinine | Baseline to week 12 and week 52 |
|
|
|
| Secondary | Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period | Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was <3.5 g/g. | Posted | Count of Participants | Participants | Baseline to week 52 |
|
|
|
| Secondary | Time to Rescue Therapy | Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis) | Due to the small sample size and early termination of the study, no data could be collected | Posted | Baseline to week 52 |
|
|
| Secondary | Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time | eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration | Data was not available for all patients at each timepoint | Posted | Mean | Full Range | mL/min/1.73m² | Baseline to Week 12 and Week 52 |
|
|
|
| Secondary | Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time | CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate | Data was not available for all patients at each timepoint | Posted | Mean | Full Range | ml/min/1.73 m² | Baseline to Week 12 and Week 52 |
|
|
|
| Secondary | Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time | CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate; | Data was not available for all patients at each timepoint | Posted | Mean | Full Range | ml/min/1.73 m² | Baseline to Week 12 and Week 52 |
|
|
|
| Secondary | Mean Change From Baseline for the MDRD Creatinine Equation Over Time | MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52 | Data was not available for all patients at each timepoint | Posted | Mean | Full Range | ml/min/1.73 m² | Baseline to Week 12 and Week 52 |
|
|
|
| Secondary | Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2 | Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health). | Due to the small sample size and early termination of the study, no data could be collected | Posted | Baseline to Week 52 |
|
|
| Secondary | Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial | Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine. | Data was not available for all patients at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 and Week 52 |
|
|
|
| Secondary | Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial | Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial | No data collected | Posted | Baseline to Day 57 |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pulpitis dental | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Ophthalmoplegic migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Tongue discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| End stage renal disease | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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