Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00042432

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 II

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:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Cinacalcet Cinacalcet hydrochloride

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

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

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.

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:	February 4, 2011
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 February 12, 2012