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
Verified date | January 2011 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
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 |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
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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