A Pilot Study to Determine the Safety and Efficacy of Induction-Therapy, De Novo MPA and Delayed mTOR-Inhibition in Liver Transplant Recipients with Impaired Renal Function - PATRON-Study - CNI-free Prevention of Rejection in Liver Transplant Patients with Impaired Renal Functio

• Conditions: Evaluation of the safety and efficacy of CNI-free immunosuppressive treatment of patients undergoing liver transplantation with a preexisting renal impairment.; MedDRA version: 9.1Level: LLTClassification code 10062237Term: Renal impairment; MedDRA version: 9.1Level: LLTClassification code 10024716Term: Liver transplantation; MedDRA version: 9.1Level: LLTClassification code 10062016Term: Immunosuppression

• Registration Number: EUCTR2007-003561-40-DE
• Lead Sponsor: Regensburg University Medical Center, Department of Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-26
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1.Patients undergoing primary liver transplantation.
2.Patients with a hepatorenal syndrome
3.eGFR < 50 ml/min at the time point of transplantation
4.Serum creatinine levels > 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

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 < 50.000/nl prior to initiation of therapy with mTOR inhibition.
8.Patients with triglycerides > 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified