Recruiting
Phase 2
Phase 3

Envarsus XR

Sponsor:

Roberto Gedaly

Code:

NCT03321656

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tacrolimus

Envarsus XR

Study Details

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

Study ID

NCT03321656

Start date

Mar 28, 2019

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Tacrolimus

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

experimental: Envarsus XR

0.07-0.14 mg/kg/day every morning orally

Interventions

Tacrolimus

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

Envarsus XR

0.07-0.14 mg/kg/day every morning orally

Primary outcome measure

  • 1. Change in the percentage of donor specific antibodies [ Time Frame: Time of transplant and six months post-transplant ]
  • Changes in the percentage of blood immunologic markers [ Time Frame: Time of transplant and six months post-transplant ]

Central Contacts and Locations

Central contacts

Deepa Valvi, DrPH

8592579443deepa.valvi@uky.edu

Locations

Deepa Valvi

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Deepa Valvi, DrPH

8592579443deepa.valvi@uky.edu

Principal Investigator:

Roberto Gedaly, MD

More Information

Sponsor

Roberto Gedaly

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Roberto Gedaly on 2026-03-24.