Patients with renal dysfunction undergoing liver transplantation MedDRA version: 14.0 Level: PT Classification code 10019846 Term: Hepatorenal syndrome System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.0 Level: LLT Classification code 10038474 Term: Renal insufficiency System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.0 Level: LLT Classification code 10024678 Term: Liver failure System Organ Class: 10019805 - Hepatobiliary disorders MedDRA
Conditions
Interventions
Trade Name: Simulect
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: basiliximab
CAS Number: 179045-86-4
Other descriptive name: BASILIXIMAB
Concentration unit:
Sponsors
University Medical Center Göttingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing primary liver transplantation. 2. Patients older than 18 years. 3. Patients with a hepatorenal syndrome 4. Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation. 5. eGFR 1.5 mg/dL at the time-point of transplantation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. Patients with pre-transplant renal replacement therapy > 14 days. 2. Patients with a reason for renal impairment other than a hepatorenal syndrome. 3. Patients with a known hypersensitivity to mTOR-inhibitors. 4. Patients with a known hypersensitivity to mycophenolate acid. 5. Patients with a known hypersensitivity to anti-CD25-monoclonal antibodies. 6. Patients with platelets 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition. 8. Severe systemic infections and wound-healing disturbances. 9. Multiple organ graft recipients. 10. Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with Sirolimus. 11. Pregnant women will not be included in the study. 12. Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule. 13. Patients under guardianship (e. g. individuals who are not able to freely give their informed consent).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to evaluate a de novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti- body (basiliximab), mycophenolic acid (MPA), and mTOR-inhibition with everolimus to determine its safety and to investigate the preliminary e?cacy in patients with impaired renal function at the time-point of liver transplantation (LT) with regards to the incidence of steroid-resistant acute rejection within the ?rst 30 days after liver transplantation. ;Secondary Objective: Secondary objectives are to assess liver and kidney function in patients receiving the proposed reno-protective immunosuppressive regimen for up to one year after liver transplantation. ;Primary end point(s): Primary endpoint in our study is the time-point of biopsy proven steroid resistant acute rejection within the ?rst 30 days after LT. ;Timepoint(s) of evaluation of this end point: within the first 30 days after LT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of acute rejections within 30 days and 3, 6 and 12 months after LT Number of acute rejections per patient Timepoint of acute rejection´s after LT Improvement and deteriration of renal function at 1, 3, 6 and 12 months in comparison to pretransplant renal function; estimated by estimated glomerular filtration rate (eGFR) calculated by MDRDformula Number of patients requiring renal replacement therapy Duration of renal replacement therapy Liver allograft function Infectious complications Treatment failure, defined as reintroduction of CNI Hemato-lymphatic side effects Incidence of hepatic artery stenoses Wound-healing disturbances Mortality ;Timepoint(s) of evaluation of this end point: up to 12 months | — |
Countries
Germany
Contacts
Public ContactAiman Obed
University Medical Center Göttingen
Outcome results
None listed