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Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
This study has been completed.
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00094484
  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 III

Drug Information available for: Cinacalcet Cinacalcet hydrochloride
U.S. FDA Resources
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks

Secondary Outcome Measures:
  • Changes in iPTH at 32 weeks.
  • Safety and tolerability of cinacalcet at 32 weeks.

Estimated Enrollment: 400
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094484

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

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

Keywords provided by Amgen:
Sensipar®
Mimpara®
Cinacalcet
Calcimimetic
Chronic Kidney Disease

Study placed in the following topic categories:
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

ClinicalTrials.gov processed this record on January 16, 2009