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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Sep 2, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a new treatment plan for kidney transplant patients who have a higher risk of rejecting their new kidney. Specifically, the study is looking at whether adding a medication called sirolimus to the standard treatment, which includes three other medications (tacrolimus, mycophenolate, and prednisone), can help improve outcomes for these patients. The goal is to see if this "quadruple immunosuppressor regimen" can reduce the chances of acute rejection of the transplanted kidney.

To participate in this trial, patients need to be sensitized kidney transplant recipients with a specific level of antibodies in their blood. They should be between the ages of 65 and 74, and they must sign a consent form agreeing to join the study. However, there are some important health criteria that could exclude potential participants, such as being obese, having certain kidney conditions, or active infections. Those who join the trial can expect to be closely monitored to assess how well the new treatment works and to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• 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.