Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: PA21 Phosphate Binder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1059
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: PA21 (2.5 g tablet containing 500 mg iron) intervention 2: Sevelamer carbonate intervention 3: PA21-1 (1.25 g tablet containing 250 mg iron)
Intervention descriptions: intervention 1: Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). intervention 2: Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day) intervention 3: Low dose comparator (1.25 g/day)

Protocol document: