A multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus.
- Conditions
- Liver transplantationreplacing a bad functioning liver by an organ from a donor1001965410029149
- Registration Number
- NL-OMON44991
- Lead Sponsor
- Stichting Leveronderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 196
* 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
*Treatment with investigational drugs within 3 months before start of therapy
*Multi organ transplantation
*cGFR < 30 ml/min
*Proteinuria > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br><br /><br>* Percentage of patients with cGFR < 60ml/min at 36 months after<br /><br>transplantation</p><br>
- Secondary Outcome Measures
Name Time Method