At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12 Month Single-center, Open Label, Randomized, Comparative Study to Evaluate Envarsus XL Steroid-free Rabbit Anti-thymocyte Globulin Induction on Renal Function and Health-related Quality of Life Following Liver Transplantation
In Brief
A Phase 2 clinical trial evaluating Envarsus XR and Prograf for Recipients of Liver Transplant. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.
Study Details
Timeline
Interventions
Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.
Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.