NCT07033858

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

Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant; Complications

Interventions

Type	Name	Description
DRUG	Rapamune Pill	Rapamiune Tablet 1mg daily plus Advograf plus prednisolone

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2026-07-01
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: Iran