RecruitingPhase 4

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

Brazil80 participantsStarted 2015-06

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Occurrence of acute rejection and/or positive viremia for CMV

Timeframe: From enrollment to the end of treatment at 52 weeks

Trial details

NCT IDNCT06584773

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Disorder Related to Renal Transplantation trials