A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability 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 Long-term Safety, Tolerability and Efficacy of PA21 Compared With Sevelamer Carbonate in Dialysis Patients With Hyperphosphataemia. Extension Study for Protocol PA-CL-05A (NCT01324128)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464190
• Other study ID #: PA-CL-05B
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2011
• Last updated: March 3, 2014
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Locations

Country	Name	City	State
Austria	Medizinische Abteilung Nephrologie und Dialyse	St. Pölten
Belgium	CHU Sart Tilman	Liege
Croatia	Clinical Hospital Center Rijeka	Rijeka
Czech Republic	Hospital with Polyclinic Novy Jicin	Novy Jicin
Germany	KfH Nierenzentrum Berlin-Neukoelln	Berlin
Latvia	Vidzemes Hospital	Valmiera
Lithuania	JSC "Diaverum Clinics"	Klaipeda
Poland	Teaching Hospital no.1 of Medical University of Lodz	Lodz
Romania	Dialmed Clinic SRL	Sibiu
Russian Federation	Kemerovo Regional hospital	Kemerovo
Serbia	Zvezdara Clinical Medical Center	Belgrade
South Africa	St Augustines Hospital	Durban
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 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.	Every 4 weeks from baseline to Week 28	No
Primary	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.	Every 4 weeks from baseline to Week 28	No
Primary	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.	Every 4 weeks from baseline to Week 28	No