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

Vifor Pharma659 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

659

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

Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

San Antonio, Texas, United States

Medizinische Abteilung Nephrologie und Dialyse

Sankt Pölten, Austria

CHU Sart Tilman

Liège, Belgium

Outcomes

Primary Outcomes

Change From Baseline and Levels at Each Time Point for Serum Phosphorus

Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Time frame: Every 4 weeks from baseline to Week 28

Change From Baseline and Levels at Each Time Point for Serum Calcium

Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Time frame: Every 4 weeks from baseline to Week 28

Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)

Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Time frame: Every 4 weeks from baseline to Week 28

Data from ClinicalTrials.gov

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