CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 97 enrolled
Drug / intervention
Tacrolimusdrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓New kidney transplant recipients
  • ✓Age 18 to 65 years
  • ✓Provided informed consent
Key exclusion· 8
  • ✕Highly sensitized patients (pretransplant T or B cell flow crossmatch positive)
  • ✕ABO incompatible kidney transplant
  • ✕Preformed donor-specific antibodies (DSA)
  • ✕HLA identical kidney transplant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03020589
NCT03020589Phase 4Completed
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Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients

University of North Carolina, Chapel Hill·interventional·Posted Jan 13, 2017·Updated Jun 26, 2023

In Brief

A Phase 4 clinical trial evaluating Tacrolimus for Renal Transplant. Completed, enrolled 97 participants across 1 site.

Detailed Summary

Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough levels and clinical outcomes. The primary endpoint of this study is to evaluate the proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplant
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartFeb 6, 2017
Primary CompletionJul 31, 2021
Study CompletionJun 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.5 years ago

Interventions

Tacrolimusdrug

See description in arm/group sections