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

Last updated: September 2, 2024
Sponsor: University of Sao Paulo General Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Everolimus

standard maintenance immunosuppression

Clinical Study ID

NCT06584773
CAAE40606115.6.000.0068
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Obese patients (body mass index above 35 m2);

  • History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary causeof renal failure;

  • Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time ofinitiation 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

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Everolimus
Phase: 4
Study Start date:
June 01, 2015
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Renal Transplantation Service

    Sao Paulo, 05403-900
    Brazil

    Site Not Available

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