NCT01324128

A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,059 (actual)
• Sponsor: Vifor Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Type	Name	Description
DRUG	PA21 (2.5 g tablet containing 500 mg iron)	Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
DRUG	Sevelamer carbonate	Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
DRUG	PA21-1 (1.25 g tablet containing 250 mg iron)	Low dose comparator (1.25 g/day)

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-10-01
• First posted: 2011-03-28
• Last updated: 2014-04-24
• Results posted: 2014-04-01

Locations

15 sites across 15 countries: United States, Austria, Belgium, Croatia, Czechia, Germany, Latvia, Lithuania, Poland, Romania, Russia, Serbia, South Africa, Ukraine, United Kingdom