CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Tacrolimusdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04645667
NCT04645667N/ACompleted
CompareCT.gov

Development of a Population Pharmacokinetic Model to Optimize Tacrolimus Dosing in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplant.

UNC Lineberger Comprehensive Cancer Center·observational·Posted Nov 27, 2020·Updated Oct 17, 2023

In Brief

An observational study evaluating Tacrolimus for Acute GVHD. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose of this research study is to evaluate tacrolimus plasma concentrations in patients who will undergo an allogeneic hematopoietic stem cell transplant (HCT). The study aims to identify associations between plasma concentrations, baseline demographic characteristics, clinical lab parameters, and genetic factors. These associations will help clinicians determine the best starting dose for tacrolimus in order to minimize risks of aGVHD and tacrolimus-induced toxicities.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute GVHD
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 27, 2020
Enrollment StartFeb 1, 2021
Primary CompletionOct 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.6 years ago

Interventions

Tacrolimusdrug

Patients will be enrolled into this group if they receive tacrolimus per standard of care. This is an observational study and no interventions will be made.