Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

Description

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.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 participants that successfully meeting inclusion criteria will be randomized (like the flipping of coin) to

Trial Eligibility

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) * Chronic use of blood thinners * Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders) * Significant or active infection * Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus * Have or have had cancer with in the past 3 years * Have taken part in another study that involved an investigational drug within the last 12 months. * Have a history of delayed or abnormal wound healing * Are pregnant or breastfeeding * Had a transfusion within the past 3 months * Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella) * Are unable or unwilling to comply with study protocol or procedures. * Current use anticoagulation medication

Study Info

Interventions

Locations Recruiting

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