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

Phase 4

Recruiting

• Conditions: Disorder Related to Renal Transplantation
• Interventions: Drug: standard maintenance immunosuppression; Drug: Everolimus

• Registration Number: NCT06584773
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2024-08
• Primary Completion: 2024-08
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.

Exclusion Criteria

• Obese patients (body mass index above 35 m2);
• History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure;
• Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus;
• Triglyceride levels greater than 300 mg/dl at enrollment;
• Active infection by hepatitis B virus, hepatitis C virus or HIV;
• CMV nonreactive IgG sorology at the time of transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard maintenance immunosuppression	standard maintenance immunosuppression	tacrolimus, mycophenolate and prednisone
fourth maintenance immunosuppressive	Everolimus	everolimus, tacrolimus, mycophenolate and prednisone

Primary Outcome Measures

Name	Time	Method
Occurrence of acute rejection and/or positive viremia for CMV	From enrollment to the end of treatment at 52 weeks	First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients.

Trial Locations

Locations (1)

Renal Transplantation Service; 🇧🇷 Sao Paulo, Brazil