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

ConditionEnd Stage Renal Disease

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorRoberto Gedaly

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Tacrolimus
Drug
0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
Envarsus XR
Drug
0.07-0.14 mg/kg/day every morning orally

Treatment groups

78 Participants

are divided into 2 treatment groups

Group A: TacrolimusActive comparator 1 intervention

Group B: Envarsus XRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1. Change in the percentage of donor specific antibodies

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.

Time frame

Time of transplant and six months post-transplant

Changes in the percentage of blood immunologic markers

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)

Time frame

Time of transplant and six months post-transplant

Secondary outcomes

Changes in creatinine clearance

Baseline creatinine will be considered the creatinine plasma levels several days after transplantation once the kidney function is stabilized.

Time frame

Time of transplant and six months post-transplant

Other outcomes

Changes in GFR

We will use the MDRD GFR equation to estimate glomerular filtration rate based on baseline creatinine and patient characteristics (age, gender and race)

Time frame

30 Days post transplant and months 3 and 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roberto Gedaly

Lead sponsor

University of Kentucky

Sponsor institution

Veloxis Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

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