Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rapamune Pill.
- Who it may be relevant to
- Registry conditions: Kidney Transplant; Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iran
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation
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).
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.
Interventions
- Drug Rapamune Pill
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone
Primary outcome measures
- Kidney function [Time frame: through study completion, an average of 1 year]
- Post-transplant viral Infections [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- All Kidney transplant recipients
Exclusion criteria
- Kidney-Pancreas transplant BMI>30 cPRA>0%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Iran · 1 center
- Nooshin Dalili — Tehran
Identifiers
NCT: NCT07033858 · SBMU-1404-2