At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
Tacrolimus Extended Release Capsule +3 moredrug
Likely dose
Mycophenolate mofetil 500mgfrom 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.
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus
In Brief
A Phase 4 clinical trial evaluating Tacrolimus Extended Release Capsule, Mycophenolate mofetil, and 2 other interventions for Immunosuppression. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunosuppression
CountriesUnited States
CollaboratorsAstellas Pharma Inc
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartMay 2017
Primary CompletionSep 2018
Study CompletionDec 2018
TodayJul 2026
First PostedNov 3, 2016
Enrollment StartMay 5, 2017
Primary CompletionSep 10, 2018
Study CompletionDec 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.7 years ago
Interventions
Tacrolimus Extended Release Capsuledrug
goal trough 5 - 12ng/mL
Mycophenolate mofetildrug
≥500mg twice a day
Prednisonedrug
goal dose 5mg daily
Mycophenolate Sodiumdrug
≥360mg twice a day