Phase 2 N=62 Randomized Single-blind Supportive Care

Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Liver Transplant · Kidney Transplant

Bottom Line

View on ClinicalTrials.gov: NCT03527238 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Tacrolimus Target Trough Level Maintenance — 38.4; 24.2 percentage of days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PPM-based Computation Assisted Drug Dosing (Other); Tacrolimus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Tacrolimus Target Trough Level Maintenance	38.4; 24.2	—

Summary

Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.

Eligibility Criteria

Inclusion Criteria

adults undergoing liver and/or kidney transplantation

Exclusion Criteria

transplant patients with contraindications to tacrolimus

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03527238). 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.