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Recruiting NCT06584773

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

Phase IV Interventional Disorder Related to Renal Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Everolimus, standard maintenance immunosuppression.
Who it may be relevant to
Registry conditions: Disorder Related to Renal Transplantation. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Everolimus
    mTORi added as the fourth maintenance immunosuppressive drug in recipients
  • Drug standard maintenance immunosuppression
    standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Primary outcome measures

  • Occurrence of acute rejection and/or positive viremia for CMV [Time frame: From enrollment to the end of treatment at 52 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Renal Transplantation Service — São Paulo

Identifiers

NCT: NCT06584773 · CAAE40606115.6.000.0068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗