NCT Number: NCT00094484
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).
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
-
Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
Secondary outcomes
-
Changes in iPTH at 32 weeks.
-
Safety and tolerability of cinacalcet at 32 weeks.
Sponsors and collaborators
Lead sponsor
Amgen
Industry
Registry information
Official study 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
Important dates
- Study start
- 2004
- First posted
- Oct 20, 2004
- Registry last updated
- May 8, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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