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

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.

Conditions

• Disorder Related to Renal Transplantation

Interventions

DRUG

Everolimus

mTORi added as the fourth maintenance immunosuppressive drug in recipients

DRUG

standard maintenance immunosuppression

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Sponsors & Collaborators

• Carlucci G Ventura

  collaborator UNKNOWN

• Daniel R Salomon

  collaborator UNKNOWN

• Fabiana Agena

  collaborator UNKNOWN

• Flavio J de Paula

  collaborator UNKNOWN

• Francine B Lemos

  collaborator UNKNOWN

• Gislene Bezerra

  collaborator UNKNOWN

• Helcio Rodrigues

  collaborator UNKNOWN

• Maria da Luz Fernandes

  collaborator UNKNOWN

• Nelson Zocoler Galante

  collaborator UNKNOWN

• Noemia B de Lima

  collaborator UNKNOWN

• Paschoalina Romano

  collaborator UNKNOWN

• Patricia S Souza

  collaborator UNKNOWN

• Vivian Onuchic

  collaborator UNKNOWN

• Elias David Neto

  collaborator UNKNOWN

• University of Sao Paulo General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2024-08-31

Completion

2025-07-31

Countries

• Brazil

Study Locations