CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Extended-release tacrolimus +1 moredrug
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/NCT04225988
NCT04225988Phase 4Completed
CompareCT.gov

A Prospective, Pilot Trial to Compare the Efficacy of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release on Suppression of Donor-Specific Antibodies in HLA Sensitized Kidney Transplant Recipients

Cedars-Sinai Medical Center·interventional·Posted Jan 13, 2020·Updated Jul 10, 2024

In Brief

A Phase 4 clinical trial evaluating Extended-release tacrolimus and Immediate-release tacrolimus for Kidney Transplant Rejection. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the incidence of biopsy-proven acute rejection at 12 months, the presence of de novo and pre-existing donor-specific HLA antibodies, estimated glomerular filtration rate, and the level of donor-derived cell-free DNA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant Rejection
CountriesUnited States
CollaboratorsVeloxis Pharmaceuticals

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJan 13, 2020
Enrollment StartJan 9, 2020
Primary CompletionJul 11, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.5 years ago

Interventions

Extended-release tacrolimusdrug

Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.

Immediate-release tacrolimusdrug

Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.