A Phase 3 Study to Investigate the Safety 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: PA21-1 (1.25 g tablet containing 250 mg iron); Drug: Sevelamer carbonate; Drug: PA21 (2.5 g tablet containing 500 mg iron)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324128

PA-CL-05A

Details and patient eligibility

About

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.

Enrollment: 1,059 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,059 participants in 3 patient groups

PA21 (2.5 g tablet)

Experimental group

Treatment:

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

Sevelamer carbonate

Active Comparator group

Treatment:

Drug: Sevelamer carbonate

PA21-1 (1.25 g tablet)

Other group

Treatment:

Drug: PA21-1 (1.25 g tablet containing 250 mg iron)