Kidney Transplant; Complications
Conditions
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.
Interventions
DRUGRapamune Pill
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All Kidney transplant recipients
Exclusion criteria
* Kidney-Pancreas transplant BMI\>30 cPRA\>0%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iran
Contacts
Primary ContactPI
Outcome results
None listed