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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324128
• Other study ID #: PA-CL-05A
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: April 3, 2014
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2014
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1059
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• PA21 (2.5 g tablet containing 500 mg iron)
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
• Sevelamer carbonate
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)
Low dose comparator (1.25 g/day)

Locations

Country	Name	City	State
Austria	LKH St. Polten	St. Polten
Belgium	CHU Sart Tilman	Liege
Croatia	Clinical Hospital Center Rijeka	Rijeka
Czech Republic	Dialysis Centre Fresenius Medical Care	Sokolov
Germany	KfH Nierenzentrum Berlin-Neukoelln	Berlin
Latvia	Vidzemes Hospital	Valmiera
Lithuania	Vilnius University Hospital Santariskiu Clinics	Vilnius
Poland	Teaching Hospital no.1 of Medical University of Lodz	Lodz
Romania	Dialmed Clinic SRL	Sibiu
Russian Federation	City Mariinsky Hospital	St. Petersburg
Serbia	Zvezdara Clinical Medical Center	Belgrade
South Africa	Lakeview Hospital	Benoni
Ukraine	Mykolayiv Regional Hospital	Mykolayiv
United Kingdom	Dorset County Hospital NHS Foundation Trust	Dorset

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Inc.	Fresenius Medical Care North America

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Croatia,  Czech Republic,  Germany,  Latvia,  Lithuania,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 24, Week 27	No
Secondary	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.	Week 12 post Baseline	No