Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: PA21 Phosphate Binder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 659
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PA21 (2.5 g tablet containing 500 mg iron) intervention 2: Sevelamer carbonate
Intervention descriptions: intervention 1: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). intervention 2: Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Protocol document: