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.

Conditions

End Stage Renal Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
End Stage Renal Disease
Intervention / Treatment

-

Contacts and Locations

Lexington

Deepa Valvi, Lexington, Kentucky, United States, 40536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Roberto Gedaly,

Roberto Gedaly, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

2026-03-31