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NCT Number: NCT06584773

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

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.

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Key information

Conditions

Disorder Related to Renal Transplantation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renal Transplantation Service

São Paulo, 05403-900, Brazil

Location status: Recruiting

Location contact

Carlucci G. Ventura, MD, PhD

SUB_INVESTIGATOR

Elias David-Neto, MD, PhD

CONTACT

[email protected]

55-11-2661-8089

Elias David-Neto, MD, PhD

PRINCIPAL_INVESTIGATOR

Fabiana Agena, RN, PhD

CONTACT

[email protected]

55-11-2661-8089

Nelson Z. Galante, MD, PhD

SUB_INVESTIGATOR

Patricia S. Souza, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everolimus

Drug

mTORi added as the fourth maintenance immunosuppressive drug in recipients

standard maintenance immunosuppression

Drug

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Primary outcomes

  1. Occurrence of acute rejection and/or positive viremia for CMV

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Carlucci G Ventura
  • Daniel R Salomon
  • Elias David Neto
  • Fabiana Agena
  • Flavio J de Paula
  • Francine B Lemos
  • Gislene Bezerra
  • Helcio Rodrigues
  • Maria da Luz Fernandes
  • Nelson Zocoler Galante
  • Noemia B de Lima
  • Paschoalina Romano
  • Patricia S Souza
  • Vivian Onuchic

Registry information

Official study title

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

Acronym: QIS

Important dates

Study start
2015
Primary completion
2024
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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