Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094484
• Other study ID #: 20000178
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2004
• Last updated: May 6, 2013
• Start date: October 2004

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Cinacalcet HCl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Chonchol M, Locatelli F, Abboud HE, Charytan C, de Francisco AL, Jolly S, Kaplan M, Roger SD, Sarkar S, Albizem MB, Mix TC, Kubo Y, Block GA. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in parti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
Secondary	Changes in iPTH at 32 weeks.
Secondary	Safety and tolerability of cinacalcet at 32 weeks.

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling