At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 261 enrolled
Drug / intervention
Envarsus XR +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.
A Prospective, Randomized, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence & Patient Reported Symptom Occurrence & Interference w/ Daily Life Comparing Envarsus XR® & Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)
In Brief
A Phase 4 clinical trial evaluating Envarsus XR and Tacrolimus twice daily for Kidney Transplant Recipients. Completed, enrolled 261 participants across 3 sites.
Detailed Summary
The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant Recipients
CountriesUnited States
CollaboratorsVeloxis Pharmaceuticals
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJul 2019
Primary CompletionMar 2022
TodayJul 2026
First PostedJun 7, 2019
Enrollment StartJul 18, 2019
Primary CompletionMar 29, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.1 years ago
Interventions
Envarsus XRdrug
Once daily Envarsus XR
Tacrolimus twice dailydrug
Twice daily tacrolimus