RecruitingPhase 2Phase 3NCT03321656

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

Sponsor

Roberto Gedaly

Enrollment

78 participants

Start Date

Mar 28, 2019

Study Type

INTERVENTIONAL

Conditions

End Stage Renal Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria14

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

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Interventions

DRUGTacrolimus

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

DRUGEnvarsus XR

0.07-0.14 mg/kg/day every morning orally

Locations(1)

Deepa Valvi

Lexington, Kentucky, United States

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NCT03321656

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