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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00189501
First received: September 12, 2005
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  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®

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

Resource links provided by NLM:

U.S. FDA Resources

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: MD Amgen
  More Information

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

No publications provided

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

Keywords provided by Amgen:
Chronic Kidney Disease, CKD,
Secondary Hyperparathyroidism, HPT

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
 Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on October 16, 2012