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NCT00352547 · ClinicalTrials.gov registry record
Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 93
- Enrollment target
NCT00352547: Completed study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00352547 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 93 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00352547 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 93 participants
- Enrollment target
Study 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 rejection. Individual differences in metabolism and excretion of sirolimus affect the patient's response to treatment. Patients who have undergone kidney transplantation at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Transplant Branch and have received sirolimus treatment will be enrolled in this study. DNA (genetic material) will be extracted from blood samples collected from transplant recipients to determine their MDR-1, CYP3A4, and CYP3A5 genotypes. Patient demographic information and data on sirolimus metabolism and excretion will be collected from the medical information system, NIDDK transplant database, and the patients' medical records. The data will be compared among patients with different genotypes (genetic constitution of an individual) and haplotypes (set of genes that code for different proteins but are inherited as a unit) to determine the effect of these gene variations on sirolimus metabolism. Information from this study may be applied to developing better dosing strategies, and thus, treatment outcomes for transplant patients receiving sirolimus.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2004-05-21 |
| Est. Completion | 2013-12-02 |
What the finished NCT00352547 record still lists
NCT00352547 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 93 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00352547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00352547 about?
NCT00352547 is a clinical study titled "Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation". 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 rejection. Individual differences in metabolism and excretion of sirolimus affect the patient's response t...
What is the current status of trial NCT00352547?
This trial is currently completed. The enrollment target is 93 participants. The study started on 2004-05-21. Estimated completion is 2013-12-02.
Who is sponsoring clinical trial NCT00352547?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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