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

Phase 3

Completed

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Drug: PA21 (2.5 g tablet containing 500 mg iron); Drug: Sevelamer carbonate

• Registration Number: NCT01464190
• Lead Sponsor: Vifor Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-03
• Primary Completion: 2012-10
• Study Completion: 2013-04
• Disposition First Submitted: 2013-08-08
• Disposition First Submitted QC: 2013-08-08
• Disposition First Posted: 2013-08-20
• Results First Submitted: 2013-12-20
• Results First Submitted QC: 2013-12-20
• Results First Posted: 2014-02-17
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 659

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PA21	PA21 (2.5 g tablet containing 500 mg iron)	-
Sevelamer carbonate	Sevelamer carbonate	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)	Every 4 weeks from baseline to Week 28	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change From Baseline and Levels at Each Time Point for Serum Calcium	Every 4 weeks from baseline to Week 28	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change From Baseline and Levels at Each Time Point for Serum Phosphorus	Every 4 weeks from baseline to Week 28	Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Trial Locations

Locations (14)

CHU Sart Tilman; 🇧🇪 Liege, Belgium

Dialmed Clinic SRL; 🇷🇴 Sibiu, Romania

KfH Nierenzentrum Berlin-Neukoelln; 🇩🇪 Berlin, Germany

Hospital with Polyclinic Novy Jicin; 🇨🇿 Novy Jicin, Czech Republic

Medizinische Abteilung Nephrologie und Dialyse; 🇦🇹 St. Pölten, Austria

Vidzemes Hospital; 🇱🇻 Valmiera, Latvia

Dorset County Hospital NHS Foundation Trust; 🇬🇧 Dorset, United Kingdom

Clinical Hospital Center Rijeka; 🇭🇷 Rijeka, Croatia

Zvezdara Clinical Medical Center; 🇷🇸 Belgrade, Serbia

St Augustines Hospital; 🇿🇦 Durban, South Africa

Mykolayiv Regional Hospital; 🇺🇦 Mykolayiv, Ukraine

JSC "Diaverum Clinics"; 🇱🇹 Klaipeda, Lithuania

Teaching Hospital no.1 of Medical University of Lodz; 🇵🇱 Lodz, Poland

Kemerovo Regional hospital; 🇷🇺 Kemerovo, Russian Federation