Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Roberto Gedaly
Summary
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Description
Participants will be identified through the Department of Transplantation Surgery at the University of Kentucky. Participants will be pre-screened by the department for entry into the study. The investigator will determine if the participant meets study eligibility requirements. The purpose of this research is to gather information on how safe and effective of Envarsus® is when compared to twice-daily tacrolimus. The results of this study will be shared with the company providing financial support for the study, the Food and Drug Administration and other federal agencies, if required. All pa…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Fluent in English able to understand and provide informed consent. * End stage renal disease listed for primary solitary kidney transplant. * Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent. * Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion. Exclusion Criteria: * Previously undergone organ, tissue or cell transplant * Allergic to Tacrolimus or MMF (Cellcept) *…
Interventions
- DrugTacrolimus
0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
- DrugEnvarsus XR
0.07-0.14 mg/kg/day every morning orally
Location
- Deepa ValviLexington, Kentucky