Text Size

Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00042432
First received: July 29, 2002
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.


Condition Intervention Phase
Secondary Hyperparathyroidism
Chronic Renal Insufficiency
 Drug: cinacalcet (AMG 073)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase [ Time Frame: Efficacy assessment phase (weeks 12-18) ] [ Designated as safety issue: No ]
    Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase


Secondary Outcome Measures:
  • Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase [ Time Frame: Baseline, efficacy assessment phase (weeks 12-18) ] [ Designated as safety issue: No ]
    Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase


Enrollment: 54
Study Start Date: June 2002
Study Completion Date: August 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cinacalcet (AMG 073) Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
Placebo Comparator: Placebo Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have chronic renal insufficiency (pre-dialysis)
  • Have below normal creatinine clearance
  • Have elevated parathyroid hormone levels

Exclusion Criteria:

  • Pregnant or nursing
  • Heart attack in the last 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042432

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00042432     History of Changes
Other Study ID Numbers: 20010239
Study First Received: July 29, 2002
Results First Received: November 4, 2010
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
 Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013