Effect of Albumin on Kidney Function After Liver Transplant
Official title: Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
Run by Rennes University Hospital · NCT06535945 · Data updated 2026-11-12
This study is testing if giving extra albumin to liver transplant patients can help prevent kidney problems after their surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Rennes University Hospital Academic / other |
| Drugs / interventions | Basiliximab |
| Locations | 8 sites (Chambray-lès-Tours and 7 other locations) |
| Status | Recruiting |
| Started | March 26, 2025 |
| Main results expected | April 26, 2028 |
| Study ends | April 26, 2028 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT06535945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are receiving a primary liver transplant from a deceased donor.
✕Probably not a fit
Patients with pre-existing kidney injury or those with fulminant hepatitis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether administering human albumin to maintain serum levels above 30g/L for five days can reduce the incidence of acute kidney injury (AKI) in patients who have undergone liver transplantation. Participants will be divided into two groups: one receiving the higher albumin concentration and the other receiving a lower concentration. The primary outcome will be the rate of AKI at Day 7 post-transplantation, comparing the two groups to assess the effectiveness of the treatment. The study aims to provide insights into optimizing post-transplant care for liver transplant recipients.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of acute kidney injury in liver transplant patients, improving their overall recovery and long-term outcomes.
How similar studies have gone: While there have been studies on albumin use in various contexts, this specific approach to liver transplantation and AKI is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
08_CHRU de Tours Hôpital Trousseau
Chambray-lès-Tours, France Recruiting -
03_APHP Hôpital Beaujon
Clichy, France Recruiting -
04_CHU de Lille Hôpital Huriez
Lille, France Recruiting -
05_HCL Hôpital de la Croix Rousse
Lyon, France Recruiting -
06_CHU de Montpellier Hôpital St Eloi
Montpellier, France Recruiting -
02_CHU de Bordeaux - Hôpital Haut Leveque
Pessac, France Recruiting
Show 2 more locations
-
01_CHU de Rennes Hôpital Pontchaillou
Rennes, France Recruiting -
09_APHP Hôpital Paul Brousse
Villejuif, France Recruiting
Study contacts
- Principal investigator: Pauline HOUSSEL-DEBRY, MD — Rennes University Hospital
- Study coordinator: Loïc JACOB
- Email: loic.jacob@chu-rennes.fr
- Phone: +33299282555
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.