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NCT01288521 · ClinicalTrials.gov registry record · Phase 4
Pharmacogenetics to Predict Drug Interactions in Kidney Transplant Recipients
A Phase 4 study, sponsored by Sony Tuteja.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT01288521 is a Phase 4 study that has completed, run by Sony Tuteja. The registered enrollment target is 8 participants.
The verdict
NCT01288521, a Phase 4 study, has completed, sponsored by Sony Tuteja.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
Solid organ transplant recipients would greatly benefit from pharmacogenetic evaluation since immunosuppressive drug regimens consist of multiple medications with narrow therapeutic ranges and toxic adverse event profiles. Tacrolimus is a potent immunosuppressive agent utilized for rejection prophylaxis. Intensive pharmacokinetic monitoring must be performed following organ transplantation to ensure therapeutic drug concentrations due to its highly variable pharmacokinetics profile and narrow therapeutic index. Tacrolimus is a substrate for CYP450 3A and for the membrane transporter p-glycoprotein (Pgp). Polymorphisms in the gene encoding for CYP3A5 have been extensively studied and have been found to influence the dosing of tacrolimus. The effect of ABCB1 gene polymorphisms (which encodes for Pgp) upon tacrolimus pharmacokinetics has been more difficult to establish. This study will determine if haplotypes derived from three frequent polymorphisms in the ABCB1 gene (C1236T, G2677T, C3435T) can predict the degree of drug interaction between tacrolimus (CYP3A5/Pgp substrate) and ketoconazole (CYP3A5/Pgp inhibitor) in patients who are CYP3A5 nonexpressors. This prospective pharmacokinetic and pharmacogenomic study will enroll 20 stable renal transplant recipients with the CYP3A5 \*3/\*3 genotype and grouped by ABCB1 haplotype (CGC vs TTT). Pharmacokinetics of tacrolimus will be assessed on 2 occasions with and without ketoconazole coadministration separated by 1 week. The order of study occasions will be randomized in a crossover design. The results of this study may identify a genomic marker for predicting drug-drug interactions. Knowing this information a priori will aid clinicians in modifying drug dosing and alleviate patients of the burden of significant drug toxicities.
Interventions
- DRUG Tacrolimus + Ketoconazole, Then Tacrolimus alone
- DRUG Tacrolimus alone, Then Tacrolimus + Ketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288521
The ClinicalTrials.gov registry entry for NCT01288521 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sony Tuteja, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus + Ketoconazole, Then Tacrolimus alone is the first listed.
NCT01288521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288521 about?
NCT01288521 is a clinical study titled "Pharmacogenetics to Predict Drug Interactions in Kidney Transplant Recipients". Solid organ transplant recipients would greatly benefit from pharmacogenetic evaluation since immunosuppressive drug regimens consist of multiple medications with narrow therapeutic ranges and toxic adverse event profiles. Tacrolimus is a potent immunosuppressive agent utilized for rejection prophyl...
What is the current status of trial NCT01288521?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2008-10. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01288521?
The interventions under investigation include: Tacrolimus + Ketoconazole, Then Tacrolimus alone (DRUG), Tacrolimus alone, Then Tacrolimus + Ketoconazole (DRUG).
Who is sponsoring clinical trial NCT01288521?
This trial is sponsored by Sony Tuteja, which has 2 total clinical trials registered on ClinicalTrials.gov.
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