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

• Registration Number: NCT01324128
• Lead Sponsor: Vifor Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-28
• Primary Completion: 2012-04
• Study Completion: 2012-10
• Disposition First Submitted: 2012-12-07
• Disposition First Submitted QC: 2012-12-10
• Disposition First Posted: 2012-12-12
• Results First Submitted: 2013-12-20
• Results First Submitted QC: 2014-03-03
• Status Verified: 2014-04
• Results First Posted: 2014-04-01
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1059

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PA21 (2.5 g tablet)	PA21 (2.5 g tablet containing 500 mg iron)	-
Sevelamer carbonate	Sevelamer carbonate	-
PA21-1 (1.25 g tablet)	PA21-1 (1.25 g tablet containing 250 mg iron)	-

Primary Outcome Measures

Name	Time	Method
Change in Serum Phosphorus Levels From Week 24 to Week 27	Week 24, 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

Secondary Outcome Measures

Name	Time	Method
Change in Serum Phosphorus Levels From Baseline to Week 12	Week 12 post Baseline	Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.

Trial Locations

Locations (14)

Dialysis Centre Fresenius Medical Care; 🇨🇿 Sokolov, Czech Republic

KfH Nierenzentrum Berlin-Neukoelln; 🇩🇪 Berlin, Germany

Dialmed Clinic SRL; 🇷🇴 Sibiu, Romania

Vilnius University Hospital Santariskiu Clinics; 🇱🇹 Vilnius, Lithuania

Lakeview Hospital; 🇿🇦 Benoni, South Africa

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

Zvezdara Clinical Medical Center; 🇷🇸 Belgrade, Serbia

City Mariinsky Hospital; 🇷🇺 St. Petersburg, Russian Federation

LKH St. Polten; 🇦🇹 St. Polten, Austria

Clinical Hospital Center Rijeka; 🇭🇷 Rijeka, Croatia

Vidzemes Hospital; 🇱🇻 Valmiera, Latvia

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

CHU Sart Tilman; 🇧🇪 Liege, Belgium

Mykolayiv Regional Hospital; 🇺🇦 Mykolayiv, Ukraine