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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06584773
Acronym
QIS
Enrollment
80
Registered
2024-09-05
Start date
2015-06-30
Completion date
2025-07-31
Last updated
2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder Related to Renal Transplantation

Keywords

kidney transplantation, sensitized, immunosuppression

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.

Interventions

DRUGEverolimus

mTORi added as the fourth maintenance immunosuppressive drug in recipients

DRUGstandard maintenance immunosuppression

standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of acute rejection and/or positive viremia for CMVFrom enrollment to the end of treatment at 52 weeksFirst occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026