A multicenter, study to assess theefficacy and safety of everolimusplus reduced tacrolimus compared to standard tacrolimusin recipients undergoing liver transplantation.
- Conditions
- Health Condition 1: null- Liver Transplantation
- Registration Number
- CTRI/2014/02/004395
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 29
• Written informed consent
• Subject aged >=18 years of a primary, orthotopic liver allograft, from a living donor
• Subject negative for HIV
Inclusion criteria at Randomization:
- Subject was initiated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression
• Subjects transplanted for acute liver failure
• HCV negative subjects receiving a transplant from HCV positive donor
• Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant.
• Subjects receiving an ABO incompatible allograft.
• MELD-score greater than 35 within 1 month prior to transplantation.
Exclusion criteria at Randomization:
• Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic artery, major/reconstructed hepatic vein, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
• Subjects with a confirmed spot urine protein/creatinine ratio that indicates greater than or equal to 1.0 g/24 hrs of proteinuria
• Subjects who have severe hypercholesterolemia (more than 350 mg/dL; more than 9 mmol/L) or hypertriglyceridemia (more than 500 mg/dL; more than 8.5 mmol/L) at randomization.
• Subjects with platelet count less than 30,000/mm3.
• Subjects with an absolute neutrophil count of less than 1,000/mm³ or white blood cell count of less than 2,000/mm³.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Composite efficacy failure of treated biopsy proven acute rejection, graft loss or death in everolimus with reduced tacrolimus group compared to standard tacrolimus [ Designated as safety issue: No ] <br/ ><br>Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR â?¥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months.Timepoint: 1. Composite efficacy failure of treated biopsy proven acute rejection, graft loss or death in everolimus with reduced tacrolimus group compared to standard tacrolimus [ Designated as safety issue: No ] <br/ ><br>Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR â?¥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months.
- Secondary Outcome Measures
Name Time Method