A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients
Overview
- Phase
- Phase 4
- Intervention
- Everolimus
- Conditions
- Liver Transplantation
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 339
- Locations
- 1
- Primary Endpoint
- Estimated Glomerular Filtration Rate (GFR)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)
Intervention: Everolimus
EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)
Intervention: Tacrolimus
EVR/TAC
Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)
Intervention: Corticosteroids
TAC
Tacrolimus (C0-h: 6-10 ng/ml)
Intervention: Tacrolimus
TAC
Tacrolimus (C0-h: 6-10 ng/ml)
Intervention: Corticosteroids
Outcomes
Primary Outcomes
Estimated Glomerular Filtration Rate (GFR)
Time Frame: month 12
The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).
Secondary Outcomes
- Estimated GFR - PP Set(month 12)
- Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death(12 months)
- Number of Participants With HCV(12 months)
- Incidence of HCV Related Fibrosis(12 months)
- Incidence and Severity of CMV Viral Infections.(12 months)
- Incidence of de Novo HCC Malignancies(12 months)