Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation (NCT06535945) | Clinical Trial Compass
RecruitingPhase 4
Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
France400 participantsStarted 2025-03-26
Plain-language summary
To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (above 30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).
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:
* Male and female subjects equal or above 18 yrs old.
* Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).
* Capability of understanding the purpose and risks of the study.
* Written informed consent
Exclusion Criteria:
* Fulminant hepatitis
* Kidney injury at baseline (Estimated Glomerular Filtration Rate \< 50 ml/min in Modification of diet in renal disease-6) including hepatorenal syndrome
* Use of an induction agent Basiliximab at liver transplantation
* Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty
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.
1This trial is specifically looking at kidney injury within the first 7 days after a liver transplant — how likely am I to develop acute kidney injury after my transplant, and does that risk make this trial worth discussing for my situation?
2Since this is a Phase 4 trial testing human albumin supplementation, which means the treatment has already been approved for use, what does my doctor think we already know about its safety compared to what this trial still needs to find out?
3The trial involves giving albumin supplements after a liver transplant — how would receiving this on top of my standard post-transplant care actually change my day-to-day experience in the hospital during those first 7 days?
4Are there standard post-transplant kidney protection strategies already in place at this hospital that I would receive regardless of whether I joined this trial, and how would those compare to what this study is testing?
5Given that this trial is still recruiting, is participating something my care team would be comfortable with alongside managing everything else involved in my liver transplant recovery?
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.