Effect of Albumin on Kidney Function After Liver Transplant
Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
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 |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Drugs / interventions | Basiliximab |
| Locations | 8 sites (Chambray-lès-Tours and 7 other locations) |
| Trial ID | NCT06535945 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving a primary liver transplant from a deceased donor.
Not a fit: Patients with pre-existing kidney injury or those with fulminant hepatitis will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 * At the time of randomisation, participation to another interventional study
Where this trial is running
Chambray-lès-Tours and 7 other locations
- 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 (Not_yet_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)
- 01_CHU de Rennes Hôpital Pontchaillou — Rennes, France (Recruiting)
- 09_APHP Hôpital Paul Brousse — Villejuif, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Pauline HOUSSEL-DEBRY, MD — Rennes University Hospital
- Study coordinator: Loïc JACOB
- Email: loic.jacob@chu-rennes.fr
- Phone: +33299282555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.