Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Disease; Chronic Kidney Disease
Intervention: Cinacalcet HCl (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Summary
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).
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
Secondary outcome: Changes in iPTH at 32 weeks.Safety and tolerability of cinacalcet at 32 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: October 2004
Last updated: December 20, 2007
|
