A prospective, phase IV study to check the effectiveness and safety of everolimus in liver transplant in Indian patients
- Conditions
- Health Condition 1: null- Liver Transplant
- Registration Number
- CTRI/2018/07/014916
- Lead Sponsor
- ovartis India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Age above 18 years of age.
Patients willing to participate in the study by providing written informed consent
Liver transplant recipient who will be receiving everolimus for the first time as per the prescribing information within six months post liver transplant.Patients should be receiving at least tacrolimus ± steroid at the time of baseline. Allograft function acceptable at time of screening as defined by AST, ALT and total bilirubin < 3 times ULN.
Contraindication as per Prescribing information .
ABO incompatible transplant.
Use of Mycophenolic acid (MPA) after baseline visit
Use of other investigational drugs at screening, or within 30 days or 5 half-lives of screening, whichever is longer.
Patient with estimated GFR < 40 /min/1.73 m2 (MDRD -4) measured anytime within one month before baseline visit.Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate renal function over time in liver transplant recipients after introduction of everolimus, measured by estimated glomerular filtration rate (eGFR by MDRD -4 formula) from baseline visit to month 12.Timepoint: From Day 0 till Month 12
- Secondary Outcome Measures
Name Time Method To evaluate Acute Rejection treated Acute Rejection Biopsy-confirmed Acute Rejection treated Biopsy-confirmed Acute Rejection at 6 month and 12 month. <br/ ><br>To evaluate incidence of Graft Loss and Death at 6 month and month 12. <br/ ><br>Timepoint: 6 month and 12 month