A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Vifor Inc.
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01464190
First received: September 12, 2011
Last updated: December 7, 2012
Last verified: December 2012
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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 hyperphosphatemia in dialysis patients. The primary objective is to assess the long-term safety and tolerability of PA21 in these patients.This is an extension study to PA-CL-05A, 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 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 |
Resource links provided by NLM:
Further study details as provided by Vifor Inc.:
Primary Outcome Measures:
- Assess the long-term safety and tolerability of PA21 [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]Assess frequency and duration of Adverse events and serious adverse events
Secondary Outcome Measures:
- long-term serum phosphate control of PA21 [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]Stability of serum phosphate levels over 28 weeks
| Estimated Enrollment: | 940 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PA21 |
Drug: PA21
Chewable Tablet The maximum dose of PA21 will be 15.0 g/day (6 tablets/day) and the minimum dose will be 5.0 g/day (2 tablets/day)
|
| Active Comparator: Sevelamer carbonate |
Drug: Sevelamer carbonate
Film coated, compressed tablets The maximum dose of sevelamer carbonate will be 14.4 g/day (18 tablets/day) and the minimum dose will be 2.4 g/day (3 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 iPTH
- Other significant medical conditions
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464190
Locations
| United States, California | |
| Balboa Nephrology | |
| Chula Vista, California, United States, 91910 | |
| California Institiute of Renal Research | |
| La Mesa, California, United States, 91942 | |
| Academic Medical Reserach Institute | |
| Los Angeles, California, United States, 90022 | |
| United States, Florida | |
| South Florida Research Institute | |
| Lauerdale Lakes, Florida, United States, 33313 | |
| Nephrology Associates of South Miami | |
| Miami, Florida, United States, 33173 | |
| United States, Georgia | |
| Georgia Kidney Associates Inc. | |
| Marietta, Georgia, United States, 30060 | |
| Davita Perry Dialysis | |
| Perry, Georgia, United States, 31069 | |
| United States, Maryland | |
| A. Kaldun Nossuli, MD | |
| Bethesd, Maryland, United States, 20814 | |
| United States, Mississippi | |
| Nephrology Associates | |
| Columbus, Mississippi, United States, 39705 | |
| Nephrology & Hypertension Associates, LTD | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Nebraska | |
| Lincoln Nephrology and Hypertension | |
| Lincoln,, Nebraska, United States, 68510 | |
| United States, Pennsylvania | |
| Northeast Cinical Research Center | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| United States, South Carolina | |
| Columbia Nephrology Associates | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Tennessee | |
| Southeast Renal Research Institute | |
| Chattanooga, Tennessee, United States, 37404 | |
| United States, Texas | |
| Research Management Inc. | |
| Austin, Texas, United States, 78758 | |
| Almeda Clinic | |
| Houston, Texas, United States, 77054 | |
| Tyler nephrology Associates | |
| Tyler, Texas, United States, 75701 | |
| United States, Wisconsin | |
| Fox Valley Nephrology Partners | |
| Neenah, Wisconsin, United States, 54956 | |
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 |
| Last Updated: | December 7, 2012 |
| 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 May 19, 2013