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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
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
Renal Insufficiency, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 26, 2014