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Advagraf Adherence in Kidney Transplant
NCT02805842Phase 3
Key facts
- Status
- Unknown
- Start
- Aug 2016
- Primary completion
- Aug 2018
- Countries
- 1
- Sponsor
- Rabin Medical Center
- Modality
- RNA-Targeting Small Molecules
- Drugs
- tacrolimus
- Conditions
- kidney transplant rejection
01
Overview
Phase 3, randomised, open-label trial of tacrolimus in kidney transplant rejection (2 arms), sponsored by Rabin Medical Center. Primary endpoint: Morisky Medical Adherence Assessment questionnaire at 2 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Tacrolimus BID
Twice daily Tacrolimus
Advagraf QD
Once daily Advagraf
03
Who it enrols
Adult kidney transplant recipients (18-60 years) receiving a first kidney transplant. Excludes patients with prior transplants, positive cross-match, PRA >50%, desensitization, recent cancer, HIV/HCV/HBsAg, or substance abuse.
04
Endpoints
Primary
Morisky Medical Adherence Assessment questionnaire
Secondary
Graft Survival
Patient Survival
Renal Function (GFR)
Incidence of Adverse Events
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