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

Amgen0 sites400 target enrollmentOctober 2004

ConditionsKidney Disease Chronic Kidney Disease

DrugsCinacalcet HCl

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Kidney Disease
Sponsor: Amgen
Enrollment: 400
Primary Endpoint: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Eligibility 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
•Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day
•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).