Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00604357
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing primary liver transplantation.
* Patients older than 18 years.
* Patients with a hepatorenal syndrome type I or II
* eGFR \< 50 ml/min at the time point of transplantation
* Serum creatinine levels \> 1.5 mg/dL at the time-point of transplantation
Exclusion Criteria:
* Patients with pre-transplant renal replacement therapy \> 14 days.
* Patients with a known hypersensitivity to mTOR-inhibitors.
* Patients with a known hypersensitivity to mycophenolate acid.
* Patients with a known hypersensitivity to anti CD 25-monoclonal antibodies.
* Patients with platelets \< 50.000/nl.
* Patients with triglycerides \> 350 mg/dl and cholesterol \> 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
* Severe systemic infections and wound-healing disturbances prior to inclusion.
* Multiple organ graft recipients.
* Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with Sirolimus.
* Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
* Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00604357
Study Brief:
Protocol Section:
NCT00604357