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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00505037 |
To evaluate the superiority to placebo, dose-responsibility and safety.
Condition | Intervention | Phase |
---|---|---|
Hyperphosphatemia Chronic Kidney Disease |
Drug: ASP1585 Drug: Placebo Drug: Sevelamer hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind-Placebo-Controlled and Open-Label-Sevelamer Hydrochloride-Controlled, Dose-Ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis |
Enrollment: | 156 |
Study Start Date: | October 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ASP1585 dose #1
|
Drug: ASP1585
Oral
|
2: Experimental
APS1585 dose #2
|
Drug: ASP1585
Oral
|
3: Experimental
ASP1585 dose #3
|
Drug: ASP1585
Oral
|
4: Placebo Comparator |
Drug: Placebo
Oral
|
5: Active Comparator |
Drug: Sevelamer hydrochloride
Oral
|
This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Astellas Pharma Inc. ( Director ) |
Study ID Numbers: | 1585-CL-0002 |
Study First Received: | July 18, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00505037 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
ASP1585 Renal Dialysis Chronic Kidney Disease Hyperphosphatemia |
Sevelamer Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Hyperphosphatemia Kidney Diseases Metabolic disorder Kidney Failure |
Phosphorus Metabolism Disorders Molecular Mechanisms of Pharmacological Action Chelating Agents Pharmacologic Actions |