NCT06584773

Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients

Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.

Conditions

• Disorder Related to Renal Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus	mTORi added as the fourth maintenance immunosuppressive drug in recipients
DRUG	standard maintenance immunosuppression	standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Timeline

• Start date: 2015-06-01
• Primary completion: 2024-08-01
• Completion: 2025-07-01
• First posted: 2024-09-05
• Last updated: 2024-09-05

Locations

1 site across 1 country: Brazil