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Envarsus XR® vs. Tacrolimus for Kidney Transplant Patients

This study is comparing two medications, Envarsus XR® and tacrolimus, in people who are getting a kidney transplant due to end-stage renal disease. The goal is to see how safe and effective Envarsus XR® is compared to tacrolimus, which is given twice a day. Researchers will look at changes in specific antibodies and other immune system markers in your blood six months after your transplant. You might be able to join if you are between 18 and 75 years old, speak English, and are scheduled for your first kidney transplant. The study is currently recruiting about 78 participants, but its overall status is unclear.

Study design
This is a single-center, randomized, controlled trial where you would be assigned to either Envarsus XR® or tacrolimus, like flipping a coin. It is an open-label study, meaning both you and your doctors will know which medication you are receiving.
What's involved
You would participate for a total of 9-18 hours over six months, attending nine study visits, each lasting 1-2 hours. You would also complete medication diaries and undergo two kidney biopsies.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure changes in your blood at the time of transplant and six months post-transplant.

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NCT03321656

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Roberto Gedaly
~78 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:TacrolimusEnvarsus XR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1. Change in the percentage of donor specific antibodies
Measured over Time of transplant and six months post-transplant
+1 more outcome measured

Conditions

End Stage Renal Disease

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Roberto Gedaly, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Deepa Valvi, DrPH
[email protected]
8592579443
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 1. Change in the percentage of donor specific antibodiesTime of transplant and six months post-transplant

    We will check these donor specific antibodies to: HLA-A, -B and -C; or HLA-DR, -DQ and -DP. We will quantify the expression of these markers by Flow Cytometry analysis and reported as mean fluorescence intensity (MFI) units.

  • Changes in the percentage of blood immunologic markersTime of transplant and six months post-transplant

    We will monitor the lymphocyte profile in blood in response to these 2 different treatments. The lymphocyte profile test will be performed by multi-parametric flow cytometry analysis with a panel of specific flourochrome-conjugated antibodies to selectively determine the following sub-populations: 1. Circulating T cells: CD4/CD8 rates and determine the following CD4 subpopulations: effector TH1, TH2, TH9, Tfh, and regulatory/suppressor T cells. 2. Circulating B cells (number and percentage of naïve, activated, memory and plasma B cells. 3. Circulating NK cells (mature and immature)