Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00110656
Collaborator
(none)
38
7
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
38 participants
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
Study Start Date
:
Mar 1, 2004
Actual Primary Completion Date
:
Sep 1, 2004
Actual Study Completion Date
:
Oct 1, 2004
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Kidney Transplant All patients entered into the study will have received a kidney transplant. |
Other: Observations
This is a non-interventional study- only observational.
|
Outcome Measures
Primary Outcome Measures
- PTH Values [12 months post kidney translplant]
Secondary Outcome Measures
- Calcium and Phosphorus [12 months post kidney transplant]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00110656
Other Study ID Numbers:
- 20030219
First Posted:
May 13, 2005
Last Update Posted:
Jan 21, 2011
Last Verified:
Jan 1, 2011
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