Clinical Trial: Cinacalcet HCl in Chronic Kidney Disease Subjects with Secondary Hyperparathyroidism Not Receiving Dialysis


	Home	\|	Search	\|	Browse	\|	Resources	\|	Help	\|	What's New	\|	About

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

This study is currently recruiting patients.

Sponsored by:	Amgen
Information provided by:	Amgen

Purpose

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).

Condition	Treatment or Intervention	Phase
Kidney Diseases Chronic Disease	Drug: Cinacalcet HCl	Phase III

MedlinePlus related topics: Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

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

Further Study Details:

Study start: October 2004

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Chronic Kidney Disease patients not receiving dialysis with:

an iPTH > 100 pg/mL [10.6 pmol/L] for subjects with stage 3 CKD or > 160 pg/mL [17.0 pmol/L] for subjects with stage 4 CKD;
a serum calcium > 9.0 mg/dL [2.25 mmol/L];
an estimated GFR < 59 mL/min and > 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).

Location and Contact Information

Amgen Call Center 866-572-6436

Arizona
Research Site, Tucson, Arizona, United States; Recruiting

Florida
Research Site, Pembroke Pines, Florida, United States; Recruiting

New York
Research Site, Flushing, New York, United States; Recruiting

Pennsylvania
Research Site, Allentown, Pennsylvania, United States; Recruiting

Research Site, Philadelphia, Pennsylvania, United States; Recruiting

Tennessee
Research Site, Jackson, Tennessee, United States; Recruiting

Research Site, Memphis, Tennessee, United States; Recruiting

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers: 20000178
Record last reviewed: October 2004
Record first received: October 19, 2004
ClinicalTrials.gov Identifier: NCT00094484
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services