Evaluation of the safety and efficacy of CNI-free immunosuppressive treatment of patients undergoing liver transplantation with a preexisting renal impairment. MedDRA version: 9.1 Level: LLT Classification code 10062237 Term: Renal impairment MedDRA version: 9.1 Level: LLT Classification code 10024716 Term: Liver transplantation MedDRA version: 9.1 Level: LLT Classification code 10062016 Term: Immunosuppression
Conditions
Interventions
Trade Name: Rapamune
Product Name: sirolimus
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
IN
Sponsors
Regensburg University Medical Center, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing primary liver transplantation. 2. Patients with a hepatorenal syndrome 3. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with pre-transplant renal replacement therapy > 14 days. 2. Patients with hepatocellular carcinoma. 3. Patients with a reason for renal impairment other than a hepatorenal syndrome. 4. Patients with a known hypersensitivity to mTOR-inhibitors. 5. Patients with a known hypersensitivity to mycophenolate acid. 6. Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies. 7. Patients with platelets 350 mg/dl and cholesterol > 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition. 9. Severe systemic infections and wound-healing disturbances. 10. Multiple organ graft recipients. 11. Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with Sirolimus. 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: Safety and efficacy of MMF, Daclizumab and Sirolimus in patients with impaired renal function undergoing liver transplantation with regard to steroid resistant biopsy proven acute rejection within the first 30 days after transplantation;Secondary Objective: 1. Incidence of acute rejections within 30 days and 3, 6 and 12 months after LT 2. Number of acute rejections per patient 3. Time-point of acute rejection(s) after LT 4. Improvement and deterioration of renal function at 1, 3, 6 and 12 months in comparison to pre-transplant renal function 5. Number of patients requiring renal replacement therapy 6. Duration of renal replacement therapy 7. Liver allograft function 8. Infectious complications 9. Treatment failure, defined as reintroduction of CNI 10. Hemato-lymphatic side effects 11. Incidence of hepatic artery stenoses 12. Wound-healing disturbances 13. Mortality ;Primary end point(s): steroid resistant acute biopsy proven rejection within the first 30 days after transplantation | — |
Countries
Germany
Outcome results
None listed