Status:
UNKNOWN
Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation
Lead Sponsor:
Armin Goralczyk
Conditions:
Liver Transplantation
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 m...
Eligibility Criteria
Inclusion
- Patients undergoing primary liver transplantation.
- Patients older than 18 years.
- Patients with a hepatorenal syndrome.
- Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation.
- eGFR \< 50 ml/min at the time point of transplantation.
- Serum creatinine levels \> 1.5 mg/dL at the time-point of transplantation.
Exclusion
- Patients with pre-transplant renal replacement therapy \> 14 days.
- Patients with a reason for renal impairment other than a hepatorenal syndrome.
- 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 prior to initiation of therapy with mTOR inhibition.
- 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.
- Multiple organ graft recipients.
- Patients with signs of a hepatic artery stenosis directly prior to initiation of therapy with everolimus.
- Pregnant women will not be included in the study.
- 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).
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00890253
Start Date
January 1 2010
End Date
January 1 2013
Last Update
September 15 2011
Active Locations (1)
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1
University Medical Center Goettingen
Göttingen, Germany, 37099