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Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00530114 |
The primary objectives of this study are the following:
Condition | Intervention | Phase |
---|---|---|
End Stage Renal Disease Chronic Kidney Disease Hyperphosphatemic Kidney Disease |
Drug: AMG 223 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia |
Estimated Enrollment: | 160 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
|
Drug: Placebo
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
|
AMG 223: Experimental
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
|
Drug: AMG 223
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amgen Call Center | 866-572-6436 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20070664 |
Study First Received: | September 13, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00530114 |
Health Authority: | United States: Food and Drug Administration |
Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Kidney Diseases Metabolic disorder Kidney Failure |
Phosphorus Metabolism Disorders |