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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00094484 |
The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).
Condition | Intervention | Phase |
---|---|---|
Kidney Disease Chronic Kidney Disease |
Drug: Cinacalcet HCl |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Chronic Kidney Disease patients not receiving dialysis with: - An iPTH greater than 100 pg/mL [10.6 pmol/L] for subjects with stage 3 CKD or greater than or equal to 160 pg/mL [17.0 pmol/L] for subjects with stage 4 CKD; - A serum calcium greater than 9.0 mg/dL [2.25 mmol/L]; - An estimated GFR less than or equal to 59 mL/min and greater than or equal to 15 mL/min. Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. - Experienced a myocardial infarction (MI) within 3 months before day 1. - Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. - Received active vitamin D therapy (i.e., 1-hydroxylated metabolites of vitamin D) for less than 30 days before day 1 or required a change in active vitamin D brand or dose level within 30 days before day 1 (for patients prescribed active vitamin D).
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000178 |
Study First Received: | October 19, 2004 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00094484 |
Health Authority: | United States: Food and Drug Administration |
Sensipar® Mimpara® Cinacalcet Calcimimetic Chronic Kidney Disease |
Parathyroid Diseases Renal Insufficiency Hyperparathyroidism, Secondary Urologic Diseases Hyperparathyroidism Renal Insufficiency, Chronic |
Kidney Failure, Chronic Neoplasm Metastasis Endocrine System Diseases Endocrinopathy Kidney Diseases Kidney Failure |