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NCT00110656 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00110656
Other study ID # 20030219
Secondary ID
Status Completed
Phase N/A
First received May 12, 2005
Last updated January 20, 2011
Start date March 2004
Est. completion date October 2004

Study information
Verified date January 2011
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date October 2004
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Observations
This is a non-interventional study- only observational.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary PTH Values 12 months post kidney translplant No
Secondary Calcium and Phosphorus 12 months post kidney transplant No
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