drugset / Trial / NCT03511560

Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

NCT03511560 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two groups using estimated glomerular filtration rate (eGFR) and also examine one-year kidney outcomes, including graft loss and patient death. Patients will be followed for up to 1 year during the open-label study period.

Timeline

Start
2018-07-26
Primary completion
2020-07-17
Completion
2021-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.12 mg/kg Oral