Status:
COMPLETED
Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Renal Transplant
Eligibility:
All Genders
Brief Summary
This study will evaluate the effects of certain genes (MDR-1, CYP3A4, and CYP3A5) on metabolism of the drug sirolimus, an immune-suppressing drug given to transplant recipients to prevent organ reject...
Detailed Description
The immunosuppressant sirolimus is a substrate for the drug efflux pump p-glycoprotein (Pgp) and the hepatic and intestinal drug metabolizing enzyme cytochrome P450 3A4/5 (CYP3A4/5). Single nucleoti...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients who meet the following criteria will be included in the study:
- Underwent kidney transplantation at the NIDDK Transplant Branch; and
- Participated in one of the NIDDK therapeutic protocols, and
- Have received or switched to sirolimus
- EXCLUSION CRITERIA:
- Patients with clearly documented non-compliance to medications including sirolimus will be excluded from the study.
Exclusion
Key Trial Info
Start Date :
May 21 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 2 2013
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00352547
Start Date
May 21 2004
End Date
December 2 2013
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892