A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
This study has been completed.
Sponsor:
Vifor Inc.
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01324128
First received: March 24, 2011
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphatemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease Requiring Chronic Dialysis |
Drug: PA21 (2.5g tablet) Drug: Sevelamer carbonate Drug: PA21-1 (1.25g tablet) |
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 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 |
Resource links provided by NLM:
Further study details as provided by Vifor Inc.:
Primary Outcome Measures:
- Efficacy (change in serum phosphate levels compared between groups) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety (adverse events, and laboratory tests, vital signs, physical exam, ECG) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 1059 |
| Study Start Date: | March 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PA21 (2.5g tablet) |
Drug: PA21 (2.5g tablet)
The maximum dose of PA21 will be 15.0 g/day and the minimum dose will be 5.0 g/day.
|
| Active Comparator: Sevelamer carbonate |
Drug: Sevelamer carbonate
The maximum dose of sevelamer carbonate will be 14.4 g/day and the minimum dose will be 2.4 g/day.
|
|
PA21-1 (1.25g tablet)
Low dose comparator
|
Drug: PA21-1 (1.25g tablet)
Low dose comparator, dose will be 1.25 g/day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Dialysis patients with hyperphosphatemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
- Stable dose of phosphate binder
- 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: NCT01324128
Locations
| United States, California | |
| Balboa Nephrology | |
| Chula Vista, California, United States, 91910 | |
| California Institute of Renal Research | |
| La Mesa, California, United States, 91942 | |
| Academic Meidcial Research Institute | |
| Los Angeles, California, United States, 90022 | |
| United States, Florida | |
| South Florida Research Institute | |
| Lauderdale 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: | NCT01324128 History of Changes |
| Other Study ID Numbers: | PA-CL-05A |
| Study First Received: | March 24, 2011 |
| Last Updated: | December 10, 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 June 18, 2013