CompletedPhase 3

CNI-free de Novo Protocol in Patients Undergoing Liver Transplantation With Renal Impairment

Germany27 participantsStarted 2008-12

Plain-language summary

Background: Patients undergoing liver transplantation with preexisting renal dysfunction are prone to further renal impairment with the early postoperative use of Calcineurin-inhibitors. However, there is only little scientific evidence for the safety and efficacy of de novo CNI free regimens in patients with impaired renal function undergoing liver transplantation. The objective of the study is to evaluate a de novo calcineurin-inhibitor-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti- body, mycophenolate mofetil (MMF/MPA), and mTOR-inhibition to determine its safety and to investigate the preliminary efficacy in patients with impaired renal function at the time of liver transplantation. Methods/Design: Patients older than 18 years with renal impairment at the time of liver transplantation due to hepatorenal syndrome, eGFR \< 50 ml/min and/or serum creatinine levels \> 1.5 mg/dL will be included. Patients will receive a combination therapy with antiCD25-monoclonal antibodies, MMF, steroids and delayed sirolimus (day 10) and will be evaluated with regards to the incidence of steroid resistant acute rejection within the first 30 days after liver transplantation as the primary endpoint. The study is designed as prospective two-step trial requiring a maximum of 29 patients. In the first step 9 patients will be included. If 8 or more patients show no signs of biopsy proven steroid resistant rejection, additional 20 patients will be included. If in the second step a total of 27 or more patients reach the primary end-point the regimen is regarded to be safe and efficient. The follow up period will be one year after transplantation. The aim is to obtain safety and efficacy data for this new and innovative therapy regimen that might be the basis for a large prospective randomized multicenter trial in the future.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary endpoint is defined as the incidence of steroid-resistant acute rejection within the first 30 days after liver transplantation.

Timeframe: 30 days

Trial details

NCT IDNCT00604357

SponsorUniversity of Regensburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-07

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