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

Vifor

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Drug: PA21 (2.5 g tablet containing 500 mg iron); Drug: Sevelamer carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464190

PA-CL-05B

Details and patient eligibility

About

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.

Enrollment: 659 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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659 participants in 2 patient groups

PA21

Experimental group

Treatment:

Drug: PA21 (2.5 g tablet containing 500 mg iron)

Sevelamer carbonate

Active Comparator group

Treatment:

Drug: Sevelamer carbonate