Study of Phosphate Levels in Patients With Chronic Kidney... | NCT00824460 | Trialant
NCT00824460
Sponsor
Vifor Pharma
Status
Completed
Last Update Posted
Apr 1, 2014Estimated
Enrollment
154Actual
Phase
Phase 2
Conditions
Chronic Kidney Disease
Interventions
1.25 g PA21 (250 mg iron)
5.0 g PA21 (1,000 mg iron)
7.5 g PA21 (1,500 mg iron)
10.0 g PA21 (2,000 mg iron)
12.5 g PA21 (2,500 mg iron)
Sevelamer hydrochloride
Countries
United States
Bulgaria
Croatia
Czechia
Germany
Poland
Romania
Russia
Switzerland
Protocol Section
Identification Module
NCT ID
NCT00824460
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PA-CL-03A
Secondary IDs
ID
Type
Description
Link
75610
Brief Title
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Official Title
An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis
Acronym
PA21
Organization
Vifor PharmaINDUSTRY
Status Module
Record Verification Date
Mar 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2008
Primary Completion Date
Oct 2009Actual
Completion Date
Mar 2010Actual
First Submitted Date
Jan 9, 2009
First Submission Date that Met QC Criteria
Jan 14, 2009
First Posted Date
Jan 16, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 20, 2013
Results First Submitted that Met QC Criteria
Mar 3, 2014
Results First Posted Date
Apr 1, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 23, 2012
Certification/Extension First Submitted that Passed QC Review
Jul 31, 2012
Certification/Extension First Posted Date
Aug 7, 2012Estimated
Last Update Submitted Date
Mar 3, 2014
Last Update Posted Date
Apr 1, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vifor PharmaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Kidney Disease
Keywords
Hemodialysis
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
154Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1.25 g PA21
Experimental
Drug: 1.25 g PA21 (250 mg iron)
5.0 g PA21
Experimental
Drug: 5.0 g PA21 (1,000 mg iron)
7.5 g PA21
Experimental
Drug: 7.5 g PA21 (1,500 mg iron)
10.0 g PA21
Experimental
Drug: 10.0 g PA21 (2,000 mg iron)
12.5 g PA21
Experimental
Drug: 12.5 g PA21 (2,500 mg iron)
Sevelamer hydrochloride - active control
Experimental
Drug: Sevelamer hydrochloride
Interventions
Name
Type
Description
Arm Group Labels
Other Names
1.25 g PA21 (250 mg iron)
Drug
Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
1.25 g PA21
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
6 weeks after baseline
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Serum-phosphate Levels at Week 2
2 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 4
4 weeks after baseline
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Main Inclusion Criteria:
≥ 18 years of age,
Receiving stable maintenance hemodialysis 3 times a week
On restricted phosphate diet at screening and throughout study
Receiving stable dose of phosphate binder for at least 1 month
Serum phosphate levels >1.78 mmol/L
Main Exclusion Criteria:
Uncontrolled hyperphosphatemia
Hypercalcemia at screening or during washout
Serum calcium < 1.9 mmol/L (<7.6 mg/dL)
Severe hyperparathyroidism (iPTH levels >600 ng/L)
Pregnancy or lactation
Iron deficiency anemia
History of hemochromatosis or ferritin >800 mg/L,
Hepatitis B, hepatitis C or other significant concurrent liver disorders
Known positivity to HIV
Use of oral iron preparations 1 month before screening,
Serious medical condition or uncontrolled systemic disease
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
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
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
FG001
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Spain
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
5.0 g PA21 (1,000 mg iron)
Drug
Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
5.0 g PA21
7.5 g PA21 (1,500 mg iron)
Drug
Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
7.5 g PA21
10.0 g PA21 (2,000 mg iron)
Drug
Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
10.0 g PA21
12.5 g PA21 (2,500 mg iron)
Drug
Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
12.5 g PA21
Sevelamer hydrochloride
Drug
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Sevelamer hydrochloride - active control
Change From Baseline in Serum-phosphate Levels at Week 5
5 weeks after baseline
Denver
Colorado
80220
United States
Pines Clinical Research
Pembroke Pines
Florida
33028
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
Nephrology Associates
Fresh Meadows
New York
11365
United States
University Hospitals / Case Medical Center
Cleveland
Ohio
44106
United States
Southeast Renal Research Institute
Chattanooga
Tennessee
37404
United States
Nephrology Associates
Nashville
Tennessee
37205
United States
Southwest Houston Research
Houston
Texas
77099
United States
MHAT
Gabrovo
5300
Bulgaria
MHAT Plovdiv
Plovdiv
4003
Bulgaria
Department of Haemodialysis at MHAT
Rousse
7002
Bulgaria
5th MHAT Sofia
Sofia
1233
Bulgaria
SHATCVD - National Cardiology Hospital
Sofia
1309
Bulgaria
MHAT "Tokuda Hospital Sofia"
Sofia
1407
Bulgaria
UMHAT "Alexandrovska" Dialysis Clinic
Sofia
1431
Bulgaria
UMHAT "Sveti Ivan Rilski"
Sofia
1431
Bulgaria
UMHAT "Sveta Anna"
Sofia
1784
Bulgaria
MDHAT Department of Haemodialysis and Nephrology
Veliko Tarnovo
5000
Bulgaria
Opca bonica Bjelovar
Bjelovar
43000
Croatia
Opca bolnica Karlovac
Karlovac
47000
Croatia
Opca bolnica
Koprivnica
48000
Croatia
Klinicka bolnica Osijek
Osijek
31000
Croatia
Klinicki bolnicki centar Rijeka
Rijeka
51000
Croatia
Klinicki bolnicki centar Split
Split
21000
Croatia
Opca bolnica Zadar
Zadar
23000
Croatia
Klinicka bolnica
Zagreb
10000
Croatia
Poliklinika Sveti Duh II
Zagreb
10000
Croatia
Klinicka bolnica Dubrava
Zagreb
10040
Croatia
Innef a.s. Hemodialyzancni stredisko
Brno
60200
Czechia
Nemocnice Nove Mesto na Morave
Nove Město Na Morave
59231
Czechia
Nemocnice s poliklinikou v Novem Jicine
Nový Jičín
74101
Czechia
Klinika nefrologie VFN
Prague
2
Czechia
Nephrologische Gemeinschaftspraxis und Dialysezentrum
Dortmund
44263
Germany
Marienhospital
Herne
44625
Germany
Niepubliczny Zaklad Opieki Zdrowotnej
Golub-Dobrzyń
87-400
Poland
Katedra i Klinika Nefrologii
Katowice
40-027
Poland
NZOZ Dializa
Olkusz
32-300
Poland
Katedra i Klinika Nefrologii
Poznan
60-355
Poland
Samodzielny Specjalistyczny
Siedlce
26
Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Sieradz
98-200
Poland
Centrum Dializy i Diagnostyki
Warsaw
01-809
Poland
Institutul Clinic Fundeni
Bucharest
022328
Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest
050098
Romania
Spitalul Clinic
Lasi
700503
Romania
SC Renamed Nefrodial SRL
Oradea
410562
Romania
S.C. Avitum S.R.L
Târgu Mureş
540136
Romania
GOU VPO Kazan
Kazan'
420064
Russia
GUZ City Clinical Hospital
Moscow
125284
Russia
MUZ City Clinical Hospital
Novosibirsk
630120
Russia
Saint-Petersburg CUS City Mariinskaya Hospital
Saint Petersburg
191104
Russia
Saint-Petersburg GUZ City Clinical Hospital
Saint Petersburg
195257
Russia
GOU VPO
Saint Petersburg
195607
Russia
Saint-Petersburg GUZ City Hospital
Saint Petersburg
196247
Russia
GOU VPO
Saint Petersburg
197089
Russia
CUS City Hospital
Saint Petersburg
198205
Russia
MLPU Clinical City Hospital
Smolensk
214001
Russia
Kantonspital Aarau
Aarau
5001
Switzerland
Chuv Lausanne
Lausanne
1011
Switzerland
Universitatsspital Zurich
Zurich
8091
Switzerland
FG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
FG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0 g PA21 (8 tablets)
FG004
12.5 g PA21 (2,500 mg Iron)
Daily dose of 12.5 g PA21 (10 tablets)
FG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
FG00026 subjects
FG00126 subjects
FG00225 subjects
FG00327 subjects
FG00424 subjects
FG00526 subjects
COMPLETED
FG00018 subjects
FG00117 subjects
FG00220 subjects
FG00315 subjects
FG00415 subjects
FG00518 subjects
NOT COMPLETED
FG0008 subjects
FG0019 subjects
FG0025 subjects
FG00312 subjects
FG0049 subjects
FG0058 subjects
For baseline characteristics data, from All Randomised patients was used.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
BG001
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
BG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
BG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0g PA21 (8 tablets)
BG004
12.5g PA21 (2,500 mg Iron)
Daily dose of 12.5 g PA21 (10 tablets)
BG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00126
BG00225
BG00327
BG00424
BG00526
BG006154
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
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.1± 12.29
BG00159.7± 13.80
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0017
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0014
BG002
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 Serum-phosphate Levels at the End of Treatment.
For the Primary Outcome, data from the Full Analysis Set (FAS) was used. The FAS consists of all randomised subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Posted
Mean
Standard Deviation
mmol/L
6 weeks after baseline
ID
Title
Description
OG000
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
OG001
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
OG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
OG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0 g PA21 (8 tablets)
OG004
12.5g PA21 (2,500 mg Iron)
Daily dose of 12.5 g PA21 (10 tablets)
OG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
Units
Counts
Participants
OG00026
OG00126
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.042± 0.650
OG001-0.348± 0.684
OG002-0.404± 0.391
OG003
Secondary
Change From Baseline in Serum-phosphate Levels at Week 2
For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2.
Posted
Mean
Standard Deviation
mmol/L
2 weeks after baseline
ID
Title
Description
OG000
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
OG001
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
OG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
OG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0 g PA21 (8 tablets)
OG004
12.5 g PA21 (2,500 mg Iron)
Secondary
Change From Baseline in Serum-phosphate Levels at Week 4
For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4.
Posted
Mean
Standard Deviation
mmol/L
4 weeks after baseline
ID
Title
Description
OG000
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25g PA21 (1 tablet)
OG001
5.0g PA21 (1,000 mg Iron)
Daily dose of 5.0g PA21 (4 tablets)
OG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5g PA21 (6 tablets)
OG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0g PA21 (8 tablets)
OG004
12.5g PA21 (2,500 mg Iron)
Secondary
Change From Baseline in Serum-phosphate Levels at Week 5
For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Number of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5.
Posted
Mean
Standard Deviation
mmol/L
5 weeks after baseline
ID
Title
Description
OG000
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
OG001
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
OG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
OG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0 g PA21 (8 tablets)
OG004
12.5 g PA21 (2,500 mg Iron)
Time Frame
Not provided
Description
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
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
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
2
26
13
26
EG001
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
2
26
16
26
EG002
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
1
25
13
25
EG003
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0 g PA21 (8 tablets)
1
27
18
27
EG004
12.5 g PA21 (2,500 mg Iron)
Daily dose of 12.5 g PA21 (10 tablets)
2
24
17
24
EG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
2
26
13
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected25 at risk
EG0030 events0 affected27 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected26 at risk
Diverticular perforation
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected25 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 11.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (11.1)
Systematic Assessment
EG0002 affected26 at risk
EG0014 affected26 at risk
EG0022 affected25 at risk
EG0038 affected27 at risk
EG0047 affected24 at risk
EG0052 affected26 at risk
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (11.1)
Systematic Assessment
EG0004 affected26 at risk
EG0013 affected26 at risk
EG0021 affected25 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (11.1)
Systematic Assessment
EG0002 affected26 at risk
EG0012 affected26 at risk
EG0021 affected25 at risk
EG003
Faeces Discoloure
Gastrointestinal disorders
MedDRA (11.1)
Systematic Assessment
EG0002 affected26 at risk
EG0013 affected26 at risk
EG0023 affected25 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (11.1)
Systematic Assessment
EG0001 affected26 at risk
EG0012 affected26 at risk
EG0022 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (11.1)
Systematic Assessment
EG0000 affected26 at risk
EG0011 affected26 at risk
EG0021 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (11.1)
Systematic Assessment
EG0000 affected26 at risk
EG0012 affected26 at risk
EG0020 affected25 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Systematic Assessment
EG0001 affected26 at risk
EG0011 affected26 at risk
EG0022 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA (11.1)
Systematic Assessment
EG0001 affected26 at risk
EG0010 affected26 at risk
EG0022 affected25 at risk
EG003
Hypotension
Vascular disorders
MedDRA (11.1)
Systematic Assessment
EG0000 affected26 at risk
EG0011 affected26 at risk
EG0020 affected25 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (11.1)
Systematic Assessment
EG0000 affected26 at risk
EG0010 affected26 at risk
EG0020 affected25 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (11.1)
Systematic Assessment
EG0000 affected26 at risk
EG0010 affected26 at risk
EG0023 affected25 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Information
Vifor Pharma
41 58 851 8222
medinfo@viforpharma.com
ID
Term
D051436
Renal Insufficiency, Chronic
Ancestor Terms
ID
Term
D051437
Renal Insufficiency
D007674
Kidney Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D007501
Iron
D000069603
Sevelamer
Ancestor Terms
ID
Term
D019216
Metals, Heavy
D004602
Elements
D007287
Inorganic Chemicals
D028561
Transition Elements
D008670
Metals
D011073
Polyamines
D000588
Amines
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG00014
BG00118
BG00214
BG00317
BG00414
BG00516
BG00693
>=65 years
BG00012
BG0018
BG00211
BG00310
BG00410
BG00510
BG00661
61.9
± 13.71
BG00360.6± 12.74
BG00459.3± 12.32
BG00561.1± 11.00
BG00660.5± 12.50
9
BG00310
BG00411
BG00511
BG00657
Male
BG00017
BG00119
BG00216
BG00317
BG00413
BG00515
BG00697
3
BG0034
BG0042
BG0054
BG00621
Czech Republic
Title
Measurements
BG0000
BG0013
BG0020
BG0030
BG0043
BG0052
BG0068
Poland
Title
Measurements
BG0004
BG0012
BG0023
BG0032
BG0040
BG0054
BG00615
Romania
Title
Measurements
BG0002
BG0014
BG0022
BG0033
BG0041
BG0050
BG00612
Croatia
Title
Measurements
BG0005
BG0013
BG0029
BG0038
BG0048
BG0057
BG00640
Russian Federation
Title
Measurements
BG0007
BG0015
BG0023
BG0035
BG0042
BG0056
BG00628
Bulgaria
Title
Measurements
BG0003
BG0013
BG0025
BG0034
BG0047
BG0051
BG00623
Germany
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
BG0062
Switzerland
Title
Measurements
BG0000
BG0012
BG0020
BG0031
BG0041
BG0051
BG0065
25
OG00424
OG00524
-0.644
± 0.551
OG004-0.547± 0.584
OG005-0.341± 0.436
Daily dose of 12.5 g PA21 (10 tablets)
OG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
Units
Counts
Participants
OG00026
OG00126
OG00225
OG00324
OG00424
OG00524
Title
Denominators
Categories
Title
Measurements
OG000-0.03± 0.55
OG001-0.36± 0.35
OG002-0.41± 0.40
OG003-0.47± 0.62
OG004-0.46± 0.45
OG005-0.41± 0.44
Daily dose of 12.5g PA21 (10 tablets)
OG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
Units
Counts
Participants
OG00024
OG00123
OG00222
OG00321
OG00421
OG00522
Title
Denominators
Categories
Title
Measurements
OG000-0.03± 0.39
OG001-0.39± 0.45
OG002-0.32± 0.54
OG003-0.58± 0.53
OG004-0.53± 0.48
OG005-0.53± 0.35
Daily dose of 12.5 g PA21 (10 tablets)
OG005
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)