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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01464190
Study type Interventional
Source Vifor Inc.
Contact
Status Completed
Phase Phase 3
Start date September 2011
Completion date April 2013
View Details
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