drugset / Trial / NCT06584773
Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
Phase 4
Recruiting
80 enrolled
University of Sao Paulo General Hospital
Carlucci G Ventura · collabDaniel R Salomon · collabElias David Neto · collabFabiana Agena · collabFlavio J de Paula · collabFrancine B Lemos · collabGislene Bezerra · collabHelcio Rodrigues · collabMaria da Luz Fernandes · collabNelson Zocoler Galante · collabNoemia B de Lima · collabPaschoalina Romano · collabPatricia S Souza · collabVivian Onuchic · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2024-08
- Completion
- 2025-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | — | — |
| Comparator | Mycophenolate Sodium | Unknown | — | — |
| Comparator | Prednisone | Other / unclassified | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |