Full Text View
Tabular View
No Study Results Posted
Related Studies
Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
This study has been completed.
Study NCT00094484   Information provided by Amgen
First Received: October 19, 2004   Last Updated: July 9, 2009   History of Changes

October 19, 2004
July 9, 2009
October 2004
 
Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
*Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
Complete list of historical versions of study NCT00094484 on ClinicalTrials.gov Archive Site
  • Changes in iPTH at 32 weeks.
  • Safety and tolerability of cinacalcet at 32 weeks.
  • "*Changes in iPTH at 32 weeks.
  • *Safety and tolerability of cinacalcet at 32 weeks."
 
Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
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

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).

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
  • Kidney Disease
  • Chronic Kidney Disease
Drug: Cinacalcet HCl
 
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 participants with CKD not receiving dialysis. Am J Kidney Dis. 2009 Feb;53(2):197-207. Epub 2008 Dec 24.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
400
 
 

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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00094484
Global Development Leader, Amgen Inc.
20000178
Amgen
 
Study Director: MD Amgen
Amgen
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP