Liver transplantation MedDRA version: 19.0 Level: LLT Classification code 10050434 Term: Prophylaxis against liver transplant rejection System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Advagraf
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
Foundation of Liver Research (SLO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Primary liver transplantation or retransplantation within 14 days after first transplantation • Use of Advagraf at least 2 weeks prior to randomization • Patent hepatic artery • Closed abdominal wound • Stable graft function • Positive informed consent at time of randomization • Age 18-70 years 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: • Treatment with investigational drugs within 3 months before start of therapy • Multi organ transplantation • cGFR 800 mg/24 h • Hypersensitivity to sirolimus • Thrombocytes < 50 x 109 /L • Leukocytes < 2.5 x 109 /L • Haemoglobin < 6 mmol/L • Biopsy proven rejection 2 weeks prior to randomization • HIV positivity • Signs of recurrent or de novo cancer • Pregnancy or breast feeding • Systemic infection • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to compare the both therapy regimens with regard to effectiveness and safety (renal function);Secondary Objective: Secondary objectives are: compare incidence of de novo malignancy at month 36 after transplantation compare incidence and severity of BPAR at month 12, 24 and 36 evaluate renal function evaluate development of NODM at month 12, 24 and 36 evaluate the prevalence of side effects at month 12, 24 and 36 evaluate quality of life evaluate the percentage of treatment switchers;Primary end point(s): •Percentage of patients with cGFR < 60ml/min at 36 months after transplantation ;Timepoint(s) of evaluation of this end point: 3 years after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of de novo malignancy at 36 months after transplantation • Incidence of and time to recurrent malignancy • Biopsy proven rejection • Retransplantation • Percentage of patients with cGFR <60ml/min at 12 and 24 months after transplantation • Incidence of de novo diabetes mellitus at 12, 24 and 36 months after transplantation • Quality of life using Eq5D questionnaires at 12, 24 and 36 months after transplantation • Severity of fatigue using FSS at 12, 24 and 36 months after transplantation • Safety (serious adverse events) • Tolerability of combination sirolimus and extended release tacrolimus • Percentage of patients on combination sirolimus and extended release tacrolimus converted to monotherapy extended release tacrolimus due to lack of tolerability or efficacy of combination sirolimus and extended release tacrolimus.;Timepoint(s) of evaluation of this end point: 12, 24 and 36 months after transplantation | — |
Countries
Netherlands
Contacts
Public ContactElke Verhey
Foundation of Liver Research
Outcome results
None listed