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

NCT06584773 | Recruiting Phase 4

• 1 other identifier: CAAE40606115.6.000.0068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

kidney transplantation, sensitized, immunosuppression

Outcome Measures

Primary Outcomes (1)

• Occurrence of acute rejection and/or positive viremia for CMV

  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

Study Arms (2)

standard maintenance immunosuppression

ACTIVE COMPARATOR

tacrolimus, mycophenolate and prednisone

Drug: standard maintenance immunosuppression

fourth maintenance immunosuppressive

EXPERIMENTAL

everolimus, tacrolimus, mycophenolate and prednisone

Drug: Everolimus

Interventions

Everolimus DRUG

mTORi added as the fourth maintenance immunosuppressive drug in recipients

fourth maintenance immunosuppressive

standard maintenance immunosuppression DRUG

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

standard maintenance immunosuppression

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Renal Transplantation Service

São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 5, 2024
• Study Start: June 1, 2015
• Primary Completion: August 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

BR (1)