A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)

This study has been completed.

First Received: September 12, 2005 Last Updated: December 20, 2007 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00189501

Purpose

Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters

Condition	Intervention
Nephrology	Drug: Sensipar®

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)

Further study details as provided by Amgen:

Estimated Enrollment:	1000
Study Start Date:	December 2004

Eligibility

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

Criteria

Inclusion Criteria:

3 month history of Stage 4 or Stage 5 CKD
A PTH value within 3 months of enrollment
If relevant, completion of Sensipar® study prior to enrolling in Registry Exclusion Criteria:
Females who are pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189501

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040159
Study First Received:	September 12, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00189501 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Chronic Kidney Disease, CKD,
Secondary Hyperparathyroidism, HPT

Study placed in the following topic categories:

Parathyroid Diseases
Renal Insufficiency
Hyperparathyroidism, Secondary
Urologic Diseases
Hyperparathyroidism
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Endocrine System Diseases
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms

Pathologic Processes
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Neoplasm Metastasis
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009