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Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation

Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation

Recruiting
18 years and older
All
Phase N/A
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Overview

Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf®/Astagraf XL®, Astellas company).

Description

This study wants to assess the efficacy of an extended-release formulation of tacrolimus (Advagraf®/Astagraf XL®) used in conjunction with an mTOR-inhibitor agent (sirolimus ) instead of MMF to evaluate the hypothesis that this regimen is associated with good allograft outcome, and might also prevent late-onset cytomegalovirus infection. Advagraf®-based immunosuppression given to de novo kidney-transplant recipients may also increase patients' adherence to treatment due to once-daily usage of the drug.

Eligibility

Inclusion Criteria:

  • All Kidney transplant recipients

Exclusion Criteria:

  • Kidney-Pancreas transplant BMI>30 cPRA>0%

Study details
    Kidney Transplant; Complications

NCT07033858

Shahid Beheshti University of Medical Sciences

15 October 2025

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