Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
- Conditions
- Kidney Transplant; Complications
- Interventions
- Drug: Rapamune Pill
- Registration Number
- NCT07033858
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- All Kidney transplant recipients
- Kidney-Pancreas transplant BMI>30 cPRA>0%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Rapamune Pill Advograf plus Rapamiune plus Prednisolone
- Primary Outcome Measures
Name Time Method Kidney function through study completion, an average of 1 year gfr measurement
Post-transplant viral Infections through study completion, an average of 1 year Number of participents with positive blood tests of CMV and BK as assessed by PCR
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nooshin Dalili
🇮🇷Tehran, Iran, Islamic Republic of
Nooshin Dalili🇮🇷Tehran, Iran, Islamic Republic ofNooshin Dalili, DrContact00989122404331nooshindalili4@gmail.com