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

Shahid Beheshti University of Medical Sciences

Status: Enrolling

Conditions: Kidney Transplant; Complications

Treatments: Drug: Rapamune Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT07033858

SBMU-1404-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All Kidney transplant recipients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Advograf plus Cellcept plus Prednisolone

Intervention

Other group

Description:

Advograf plus Rapamiune plus Prednisolone

Treatment:

Drug: Rapamune Pill