Health Condition 1: null- Liver Transplant
Conditions
Interventions
Intervention1: Everolimus: efficacy and safety of everolimus
Sponsors
Novartis India Limited
Novartis India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate Acute Rejection treated Acute Rejection Biopsy-confirmed Acute Rejection treated Biopsy-confirmed Acute Rejection at 6 month and 12 month. To evaluate incidence of Graft Loss and Death at 6 month and month 12. Timepoint: 6 month and 12 month | — |
Countries
India
Contacts
Public ContactDr Noopur Vyas
Novartis India Limited
Outcome results
None listed