Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
Locations
Other Locations
Brazil
Renal Transplantation Service
RECRUITING
São Paulo
Time Frame
Start Date: 2015-06
Estimated Completion Date: 2025-07
Participants
Target number of participants: 80
Treatments
Active_comparator: standard maintenance immunosuppression
tacrolimus, mycophenolate and prednisone
Experimental: fourth maintenance immunosuppressive
everolimus, tacrolimus, mycophenolate and prednisone
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital
Collaborators: Elias David Neto, Flavio J de Paula, Patricia S Souza, Gislene Bezerra, Noemia B de Lima, Vivian Onuchic, Maria da Luz Fernandes, Francine B Lemos, Helcio Rodrigues, Paschoalina Romano, Daniel R Salomon, Carlucci G Ventura, Nelson Zocoler Galante, Fabiana Agena