Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110656
First received: May 12, 2005
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney transplant.


Condition Intervention
Kidney Transplantation
Other: Observations

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective Follow Up Study to Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • PTH Values [ Time Frame: 12 months post kidney translplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium and Phosphorus [ Time Frame: 12 months post kidney transplant ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Retrospective data collected.


Enrollment: 38
Study Start Date: March 2004
Study Completion Date: October 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Kidney Transplant
All patients entered into the study will have received a kidney transplant.
Other: Observations
This is a non-interventional study- only observational.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.

Criteria

Inclusion Criteria:

- Patients who withdrew from one of the qualifying studies (i.e. patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) due to kidney transplantation.

Exclusion Criteria:

- Patient has any kind of disorder that compromises the ability of the subject to give written informed consent

  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: NCT00110656

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: NCT00110656     History of Changes
Other Study ID Numbers: 20030219
Study First Received: May 12, 2005
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Kidney transplant

ClinicalTrials.gov processed this record on July 24, 2014