An interventional study of Rapamune Pill in Kidney Transplant; Complications, sponsored by Shahid Beheshti University of Medical Sciences. Recruiting at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Treatment
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).
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.
Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Advograf plus Cellcept plus Prednisolone
Advograf plus Rapamiune plus Prednisolone
Drug: Rapamune Pill
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone
Also known as: Sirolimus
Kidney function
gfr measurement
Time frame: through study completion, an average of 1 year
Post-transplant viral Infections
Number of participents with positive blood tests of CMV and BK as assessed by PCR
Time frame: through study completion, an average of 1 year
Started Mar 2025 (actual). Primary completion is estimated for Mar 2026, 12 months after the start.
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Studies of the drug tested here: Sirolimus
Shahid Beheshti University of Medical Sciences →