NCT01464190

A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability 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 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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 659 (actual)
• Sponsor: Vifor Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2013-04-01
• First posted: 2011-11-03
• Last updated: 2014-04-01
• Results posted: 2014-02-17

Locations

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