Trial · NCT01464190

A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

NCT01464190, Phase 3, Completed, Vifor Pharma; results first posted 2014-02-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients. Trials, record NCT01464190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01464190

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
NCT number: NCT01464190
Status: Completed
Phases: Phase 3
Enrollment: 659 participants, actual
Lead sponsor: Vifor Pharma
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Interventions: PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate
First posted: 2011-11-03
Last updated: 2014-04-01
Results first posted: 2014-02-17

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Every 4 weeks from baseline to Week 28	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Primary	Change From Baseline and Levels at Each Time Point for Serum Calcium	Every 4 weeks from baseline to Week 28	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Primary	Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)	Every 4 weeks from baseline to Week 28	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Every 4 weeks from baseline to Week 28	For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.	mg/dL	MEAN
PRIMARY	Change From Baseline and Levels at Each Time Point for Serum Calcium	Every 4 weeks from baseline to Week 28	For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.	mg/dL	MEAN
PRIMARY	Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)	Every 4 weeks from baseline to Week 28	For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.	pg/mL	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	PA21	Change from Baseline to Week 4 (n = 346, 236)	-0.2	Standard Deviation 1.33	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Sevelamer Carbonate	Change from Baseline to Week 4 (n = 346, 236)	-0.1	Standard Deviation 1.47	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	PA21	Change from Baseline to Week 8 (n = 325, 238)	-0.2	Standard Deviation 1.38	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Sevelamer Carbonate	Change from Baseline to Week 8 (n = 325, 238)	0.1	Standard Deviation 1.56	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	PA21	Change from Baseline to Week 12 (n = 322, 242)	-0.0	Standard Deviation 1.43	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Sevelamer Carbonate	Change from Baseline to Week 12 (n = 322, 242)	0.2	Standard Deviation 1.55	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	PA21	Change from Baseline to Week 16 (n = 313, 228)	0.0	Standard Deviation 1.57	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Sevelamer Carbonate	Change from Baseline to Week 16 (n = 313, 228)	0.2	Standard Deviation 1.75	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	PA21	Change from Baseline to Week 20 (n = 300, 221)	-0.0	Standard Deviation 1.46	mg/dL
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Sevelamer Carbonate	Change from Baseline to Week 20 (n = 300, 221)	0.1	Standard Deviation 1.44	mg/dL

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PA21	391
Overall Study	STARTED	Sevelamer Carbonate	268
Overall Study	COMPLETED	PA21	322
Overall Study	COMPLETED	Sevelamer Carbonate	227
Overall Study	NOT COMPLETED	PA21	69
Overall Study	NOT COMPLETED	Sevelamer Carbonate	41

Source ClinicalTrials.gov

Adverse events334

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	PA21	15	391	16
other	Anaemia	Blood and lymphatic system disorders	Sevelamer Carbonate	15	267	17
other	Diarrhoea	Gastrointestinal disorders	PA21	32	391	43
other	Diarrhoea	Gastrointestinal disorders	Sevelamer Carbonate	15	267	19
other	Headache	Nervous system disorders	PA21	20	391	28
other	Headache	Nervous system disorders	Sevelamer Carbonate	8	267	19
other	Hyperkalaemia	Metabolism and nutrition disorders	PA21	17	391	31
other	Hyperkalaemia	Metabolism and nutrition disorders	Sevelamer Carbonate	16	267	28
other	Hyperparathyroidism secondary	Endocrine disorders	PA21	15	391	15
other	Hyperparathyroidism secondary	Endocrine disorders	Sevelamer Carbonate	23	267	25

1 to 10 of 334Source ClinicalTrials.gov

See all 334 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PA21
Total, all-cause mortality	Sevelamer Carbonate
Total, other adverse events	PA21	208	391
Total, other adverse events	Sevelamer Carbonate	169	267
Total, serious adverse events	PA21	78	391
Total, serious adverse events	Sevelamer Carbonate	52	267

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29656600	DERIVED	PubMed
40576086	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
PA21 vs Sevelamer Carbonate: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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