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Recruiting

NCT Number: NCT07033858

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

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).

Recruiting

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Key information

Conditions

Kidney Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All Kidney transplant recipients

Exclusion criteria

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

Treatment and study plan

Rapamune Pill

Drug

Rapamiune Tablet 1mg daily plus Advograf plus prednisolone

Other names: Sirolimus

Primary outcomes

  1. Kidney function

    Time frame: through study completion, an average of 1 year

    gfr measurement

  2. Post-transplant viral Infections

    Time frame: through study completion, an average of 1 year

    Number of participents with positive blood tests of CMV and BK as assessed by PCR

Study contacts

Contact information is provided by the study sponsor or research team.

PI

CONTACT

[email protected]

00989122404331

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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