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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Inc.; Vifor Pharma
• Collaborator: Fresenius Medical Care North America
• Treatments: Iron; Sevelamer

Criteria

Inclusion Criteria:

• Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)

• Stable dose of phosphate binder

• Written informed consent

Exclusion Criteria:

• Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)

• Other significant medical conditions

• Pregnancy