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Sirolimus Addition in Sensitized Kidney Transplant Recipients
NCT02208791Phase 4
Key facts
- Status
- Unknown
- Start
- Jul 2014
- Primary completion
- Jul 2016
- Countries
- 1
- Sponsor
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- kidney transplant rejection
01
Overview
Phase 4, randomised, open-label trial of sirolimus in kidney transplant rejection (2 arms), sponsored by Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Primary endpoint: Composite of graft loss and/or death with graft function at 1 year. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Tacrolimus/MPS/Prednisone
Standard triple immunosuppression
Sirolimus/Low Tacrolimus/MPS/Prednisone
Addition of Sirolimus with reduced Tacrolimus and MPS
03
Who it enrols
Kidney transplant recipients aged 18-60 with PRA > 20% and GFR > 29 ml/min, on tacrolimus/MPS/prednisone.
04
Endpoints
Primary
Composite of graft loss and/or death with graft function
Secondary
Number of participants with serious and non-serious adverse events
Incidence of biopsy proven acute allograft rejection
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