Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Secondary Hyperparathyroidism Clinical Trial

Official title:

A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042432
• Other study ID #: 20010239
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2002
• Last updated: May 9, 2013
• Start date: June 2002
• Est. completion date: August 2003

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Mean iPTH of = 30% During the Efficacy Assessment Phase	Reduction in mean intact parathyroid hormone (iPTH) of = 30% within the participant during the efficacy assessment phase	Efficacy assessment phase (weeks 12-18)	No
Secondary	Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase	Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase	Baseline, efficacy assessment phase (weeks 12-18)	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling