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Sponsored by: |
Vifor Pharma |
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Information provided by: | Vifor Pharma |
ClinicalTrials.gov Identifier: | NCT00824460 |
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease |
Drug: PA21 Drug: Renagel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized, Active Controlled Multi Center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis |
Estimated Enrollment: | 252 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1.25 g PA21: Experimental |
Drug: PA21
Comparison of different doses of PA21
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5g PA21: Experimental |
Drug: PA21
Comparison of different doses of PA21
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7.5 g of PA21: Experimental |
Drug: PA21
Comparison of different doses of PA21
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10g of PA21: Experimental |
Drug: PA21
Comparison of different doses of PA21
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12.5g PA21: Experimental |
Drug: PA21
Comparison of different doses of PA21
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active control: Experimental |
Drug: Renagel
patients will receive 4.8 g
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contact: Sylvain Gaillard | sylvain.gaillard@viforpharma.com |
Principal Investigator: | Prof. Rudolf P Wutrich, MD | Unafilliated |
Responsible Party: | Vifor Pharma ( Sylvain Gaillard ) |
Study ID Numbers: | PA-CL-03A, 75610 |
Study First Received: | January 9, 2009 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00824460 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hemodialysis |
Sevelamer Signs and Symptoms Renal Insufficiency Urologic Diseases |
Renal Insufficiency, Chronic Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |