Clinical Trial Details
| Trial ID: | L0733 |
| Source ID: | NCT00629122 |
| Associated Drug: | Tacrolimus (Arm B) |
| Title: | Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00629122/results |
| Conditions: | Kidney Failure, Chronic |
| Interventions: | DRUG: Tacrolimus (Arm B)|DRUG: Clotrimazole Troche|DRUG: Tacrolimus (Arm A)|DRUG: Nystatin Suspension |
| Outcome Measures: | Primary: C0 (ng/mL), Trough concentration, Day 3 and Day 8, time 0 (before tacrolimus dose)|Cmax, Maximum concentration (ng/mL), Day 3 and Day 8, at time of maximum concentration|Tmax, Time to Maximum concentration (hours), Day 3 and Day 8, time of maximum concentration|Estimated AUC 0-6, Area Under the Concentration-Time Curve from 0-6 hours (mg-hr/L), Day 3 and Day 8, calculated based on concentrations measured between hours 0 and 6|Tacrolimus Powder Dissolution Time, Tacrolimus Powder Dissolution Time during Sublingual Administration (minutes), Day 3, minutes to powder dissolution | Secondary: Drug Interactions and Genotypes, Impact of drug interaction between tacrolimus and clotrimazole troche vs. nystatin suspension. Evaluate genotype polymorphisms that influence CYP3A4, CYP3A5, and p-glycoprotein expression to determine impact on sublingual and oral tacrolimus delivery., 2 weeks |
| Sponsor/Collaborators: | Sponsor: Weill Medical College of Cornell University |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 5 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH |
| Start Date: | 2008-02 |
| Completion Date: | 2009-12 |
| Results First Posted: | 2017-12-11 |
| Last Update Posted: | 2019-06-12 |
| Locations: | NewYork-Presbyterian Hospital, New York, New York, 10065, United States |
| URL: | https://clinicaltrials.gov/show/NCT00629122 |
