CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,059 enrolled
Drug / intervention
PA21 (2.5 g tablet containing 500 mg iron) +2 moredrug
Likely dose
PA21 (2.5 g tablet containing 500 mg iron)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01324128
NCT01324128Phase 3Completed
CompareCT.gov

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia

Vifor Pharma·interventional·Posted Mar 28, 2011·Updated Apr 24, 2014

In Brief

A Phase 3 clinical trial evaluating PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate, and 1 other intervention for Chronic Kidney Disease Requiring Chronic Dialysis. Completed, enrolled 1,059 participants across 15 sites in 15 countries.

Detailed Summary

This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease Requiring Chronic Dialysis
CountriesAustria, Belgium, Croatia, Czechia, Germany, Latvia, Lithuania, Poland, Romania, Russia, Serbia, South Africa, Ukraine, United Kingdom, United States
CollaboratorsFresenius Medical Care North America

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 28, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.3 years ago

Interventions

PA21 (2.5 g tablet containing 500 mg iron)drug

Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

Sevelamer carbonatedrug

Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

PA21-1 (1.25 g tablet containing 250 mg iron)drug

Low dose comparator (1.25 g/day)