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

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01464190
First received: September 12, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease Requiring Chronic Dialysis
Drug: PA21 (2.5 g tablet containing 500 mg iron)
Drug: Sevelamer carbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Change From Baseline and Levels at Each Time Point for Serum Phosphorus [ Time Frame: Every 4 weeks from baseline to Week 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 4 weeks from baseline to Week 28 ] [ Designated as safety issue: No ]
    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 Intact Parathyroid Hormone (iPTH) [ Time Frame: Every 4 weeks from baseline to Week 28 ] [ Designated as safety issue: No ]
    Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.


Enrollment: 659
Study Start Date: September 2011
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 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).
Active Comparator: Sevelamer carbonate Drug: Sevelamer carbonate
Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464190

Locations
United States, Texas
San Antonio, Texas, United States, 78215
Austria
Medizinische Abteilung Nephrologie und Dialyse
St. Pölten, Austria, 3100
Belgium
CHU Sart Tilman
Liege, Belgium, 4000
Croatia
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Czech Republic
Hospital with Polyclinic Novy Jicin
Novy Jicin, Czech Republic, 74101
Germany
KfH Nierenzentrum Berlin-Neukoelln
Berlin, Germany, 12045
Latvia
Vidzemes Hospital
Valmiera, Latvia, LV-4201
Lithuania
JSC "Diaverum Clinics"
Klaipeda, Lithuania, LT-93220
Poland
Teaching Hospital no.1 of Medical University of Lodz
Lodz, Poland, 90-153
Romania
Dialmed Clinic SRL
Sibiu, Romania, 550135
Russian Federation
Kemerovo Regional hospital
Kemerovo, Russian Federation, 650029
Serbia
Zvezdara Clinical Medical Center
Belgrade, Serbia, 11000
South Africa
St Augustines Hospital
Durban, South Africa, 4001
Ukraine
Mykolayiv Regional Hospital
Mykolayiv, Ukraine, 54058
United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorset, United Kingdom, DT1 2JY
Sponsors and Collaborators
Vifor Inc.
Fresenius Medical Care North America
Investigators
Principal Investigator: Juergen Floege, MD Medizinische Klinik II
  More Information

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01464190     History of Changes
Other Study ID Numbers: PA-CL-05B
Study First Received: September 12, 2011
Results First Received: December 20, 2013
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Vifor Inc.:
PA21
Phosphate Binder

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014