Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Overview

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

Full Title of Study: “A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2003

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: cinacalcet (AMG 073)
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
    • Time Frame: Efficacy assessment phase (weeks 12-18)
    • Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase

Secondary Measures

  • Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
    • Time Frame: Baseline, efficacy assessment phase (weeks 12-18)
    • Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amgen
  • Provider of Information About this Clinical Study
    • Global Development Leader, Amgen Inc.
  • Overall Official(s)
    • MD, Study Director, Amgen

Citations Reporting on Results

Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67.

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