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

This study has been completed.

First Received: July 29, 2002 Last Updated: December 20, 2007 History of Changes

Sponsored by:	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: AMG 073	Phase II

Study Type:	Interventional
Study Design:	Treatment

Eligibility

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

Criteria

Patients must have chronic renal insufficiency (pre-dialysis); * Have below normal creatinine clearance; * Have elevated parathyroid hormone levels; * Not be pregnant or nursing; and * Not have had a 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:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 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:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010239
Study First Received:	July 29, 2002
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00042432 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Parathyroid Diseases
Hyperparathyroidism, Secondary
Renal Insufficiency
Urologic Diseases
Hyperparathyroidism

Renal Insufficiency, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy
Kidney Diseases

Additional relevant MeSH terms:

Parathyroid Diseases
Neoplasms
Neoplastic Processes
Renal Insufficiency
Hyperparathyroidism, Secondary
Pathologic Processes

Urologic Diseases
Hyperparathyroidism
Renal Insufficiency, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on September 10, 2009