A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Subjects who have completed treatment in Protocol PA-CL-05A

• Written Informed Consent

Exclusion Criteria:

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

• Other significant medical conditions

• Pregnancy