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

Vifor Pharma1,059 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,059

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

PA21 (2.5 g tablet containing 500 mg iron)DRUG

Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).

Sevelamer carbonateDRUG

Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)

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

Low dose comparator (1.25 g/day)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

San Antonio, Texas, United States

LKH St. Polten

Sankt Pölten, Austria

CHU Sart Tilman

Liège, Belgium

Outcomes

Primary Outcomes

Change in Serum Phosphorus Levels From Week 24 to Week 27

Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27

Time frame: Week 24, Week 27

Secondary Outcomes

Change in Serum Phosphorus Levels From Baseline to Week 12

Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.

Time frame: Week 12 post Baseline

Data from ClinicalTrials.gov

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