At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 29 enrolled
Drug / intervention
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.
Once-Daily Extended-Release Tacrolimus vs. Twice-Daily Tacrolimus: Impact on T-Cell Subpopulations and Markers of Renal Tubule-toxicity in Kidney Transplant Patients
In Brief
A Phase 3 clinical trial evaluating Tacrolimus and Tacrolimus Extended Release Oral Tablet [Envarsus] for End Stage Renal Disease and Rejection of Renal Transplant. Completed, enrolled 29 participants across 1 site.
Detailed Summary
The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T and B cells and alloreactive T cells as well as on renal allograft function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedSep 2017
Primary CompletionFeb 2021
TodayJul 2026
First PostedSep 21, 2017
Enrollment StartSep 5, 2017
Primary CompletionFeb 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.8 years ago
Interventions
Tacrolimusdrug
immunosuppressive agent tacrolimus, given twice-daily
Tacrolimus Extended Release Oral Tablet [Envarsus]drug
immunosuppressive agent extended-release tacrolimus, given once daily