CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 659 enrolled
Drug / intervention
PA21 (2.5 g tablet containing 500 mg iron) +1 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/NCT01464190
NCT01464190Phase 3Completed
CompareCT.gov

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)

Vifor Pharma·interventional·Posted Nov 3, 2011·Updated Apr 1, 2014

In Brief

A Phase 3 clinical trial evaluating PA21 (2.5 g tablet containing 500 mg iron) and Sevelamer carbonate for Chronic Kidney Disease Requiring Chronic Dialysis. Completed, enrolled 659 participants across 15 sites in 15 countries.

Detailed Summary

This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.

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
201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.7 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

Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).