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

Plain Language Summary

Simplified for easier understanding

This study is examining whether a specific formulation of a common anti-rejection medication called Envarsus XR (tacrolimus) reduces the risk of silent (subclinical) kidney rejection after a transplant, compared to other forms of the drug. **You may be eligible if...** - You speak and understand English well enough to give informed consent - You have kidney failure and are on the waiting list for your first kidney transplant - You are willing to follow all study requirements - Women of childbearing age must use effective birth control **You may NOT be eligible if...** - You have previously had a kidney transplant - You have a condition that makes tacrolimus unsafe for you - You are unwilling to comply with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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