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NOCTX-2: Everolimus vs Tacrolimus in Renal Transplant
NCT01276834Phase 4
Key facts
- Status
- Terminated
- Start
- Sep 2010
- Primary completion
- Jul 2012
- Countries
- 1
- Sponsor
- Dianet Dialysis Centers
- Modality
- Small Molecules
- Drugs
- everolimus
- Conditions
- kidney transplantation
01
Overview
Phase 4, randomised, open-label trial of everolimus in kidney transplantation (2 arms), sponsored by Dianet Dialysis Centers. Primary endpoint: change in coronary artery calcification score at 3 years. Started Sep 2010; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Everolimus-based
Everolimus + Prednisone + Mycophenolate
Standard (Tacrolimus)
Tacrolimus + Prednisone + Mycophenolate
03
Who it enrols
Adult renal transplant recipients with GFR >= 30 ml/min, excluding those with severe dyslipidemia, proteinuria, or high HLA sensitization.
04
Endpoints
Primary
change in coronary artery calcification score
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