Clinical Trial: 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 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).

Location and Contact Information

Amgen Call Center      866-572-6436 

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

California
      Research Site, Walnut Creek,  California,  United States; Recruiting

Colorado
      Research Site, Denver,  Colorado,  United States; Recruiting

Connecticut
      Research Site, Stamford,  Connecticut,  United States; Recruiting

      Research Site, Hartford,  Connecticut,  United States; Recruiting

District of Columbia
      Research Site, Washington,  District of Columbia,  United States; Recruiting

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

Illinois
      Research Site, Evanston,  Illinois,  United States; Recruiting

Indiana
      Research Site, Fort Wayne,  Indiana,  United States; Recruiting

      Research Site, Indianapolis,  Indiana,  United States; Recruiting

Kansas
      Research Site, Kansas City,  Kansas,  United States; Recruiting

Louisiana
      Research Site, New Orleans,  Louisiana,  United States; Recruiting

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

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

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

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

Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting

Oregon
      Research Site, Portland,  Oregon,  United States; Recruiting

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

      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting

      Research Site, Wynnewood,  Pennsylvania,  United States; Recruiting

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

      Research Site, Memphis,  Tennessee,  United States; Recruiting

      Research Site, Nashville,  Tennessee,  United States; Recruiting

Texas
      Research Site, San Antonio,  Texas,  United States; Recruiting

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers:  20000178
Record last reviewed:  February 2005
Last Updated:  February 14, 2005
Record first received:  October 19, 2004
ClinicalTrials.gov Identifier:  NCT00094484
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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