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

September 2, 2024 updated by: University of Sao Paulo General Hospital

Efficacy and Impact on CMV Infection 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Recruiting
        • Renal Transplantation Service
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elias David-Neto, MD, PhD
        • Sub-Investigator:
          • Nelson Z. Galante, MD, PhD
        • Sub-Investigator:
          • Patricia S. Souza, MD, PhD
        • Sub-Investigator:
          • Carlucci G. Ventura, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard maintenance immunosuppression
tacrolimus, mycophenolate and prednisone
Drug: standard maintenance immunosuppression
standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone
Experimental: fourth maintenance immunosuppressive
everolimus, tacrolimus, mycophenolate and prednisone
Drug: Everolimus
mTORi added as the fourth maintenance immunosuppressive drug in recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Estimated)

September 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE40606115.6.000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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