Phase 4
N=97
Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
Renal Transplant
Bottom Line
View on ClinicalTrials.gov: NCT03020589 ↗Enrolled (actual)
97
Serious AEs
6.2%
Results posted
Jul 2022
Primary outcome: Primary: Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation — 0.2; 0.14 proportion of participants — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tacrolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation |
0.2; 0.14 | 0.58 |
| PRIMARY Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 7 After Kidney Transplantation |
0.29; 0.21 | 0.46 |
| SECONDARY Number of Events of Biopsy Proven Acute Rejection (BPAR) |
3; 2; 3; 0; 0; 0 | — |
| SECONDARY Tacrolimus Level |
6.4; 7.87 | — |
| SECONDARY Mean Number of Dose Adjustments and/or Drug Alterations |
7.86; 7.37 | — |
| SECONDARY Percent of Participants With Chronic Renal Impairment by eGFR Category |
23; 24; 53; 46; 35; 42 | — |
| SECONDARY Number of Adverse Outcomes |
1; 2; 12; 17; 1; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All new kidney transplant recipients aged 18 to 65 years who are admitted at UNC-CH and provided informed consent will be included in this study.
Exclusion Criteria
- Patients will be excluded from participating in the study to receive genotype-guided tacrolimus dosing if he/she meets any of the exclusion criteria described below.
- Recipients who did not consent to participate in the study.
- Highly sensitized patients (ie, pretransplant T or B cell flow crossmatch positive)
- Recipients of ABO incompatible kidney transplant
- Recipients with preformed donor-specific antibodies (DSA)
- Human Leukocyte Antigen (HLA) identical kidney transplant
- Recipients of non-kidney transplant
- Recipients of repeat transplant if they are on immunosuppression at the time of transplant
- Patients using medications that have known pharmacokinetic (PK) drug interaction with tacrolimus
- Patients in whom tacrolimus therapy is contraindicated
Data sourced from ClinicalTrials.gov (NCT03020589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.