Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00094484
First received: October 19, 2004
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00094484
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094484
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00094484 History of Changes |
| Other Study ID Numbers: | 20000178 |
| Study First Received: | October 19, 2004 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Sensipar® Mimpara® Cinacalcet Calcimimetic Chronic Kidney Disease |
Additional relevant MeSH terms:
|
Renal Insufficiency, Chronic Kidney Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Renal Insufficiency Urologic Diseases Parathyroid Diseases |
Endocrine System Diseases Cinacalcet Hydrochloride Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 27, 2016