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

NCT03321656 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 42753
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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 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 of transplant and six months post-transplant

Secondary Outcomes (1)

• Changes in creatinine clearance

  Time of transplant and six months post-transplant

Other Outcomes (1)

• Changes in GFR

  30 Days post transplant and months 3 and 6

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally

Drug: Tacrolimus

Envarsus XR

EXPERIMENTAL

0.07-0.14 mg/kg/day every morning orally

Drug: Envarsus XR

Interventions

Tacrolimus DRUG

0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally

Tacrolimus

Envarsus XR DRUG

0.07-0.14 mg/kg/day every morning orally

Envarsus XR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roberto Gedaly: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

Deepa Valvi

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Roberto Gedaly, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepa Valvi, DrPH

CONTACT

8592579443; deepa.valvi@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Investigator

Model Details: * Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning * Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 26, 2017
• Study Start: March 28, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)