NCT06535945 Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
| NCT ID | NCT06535945 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rennes University Hospital |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2028-04-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2025-03-26 with a primary completion date of 2028-04-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)).
Eligibility 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
Contact & Investigator
Pauline HOUSSEL-DEBRY, MD
PRINCIPAL INVESTIGATOR
Rennes University Hospital
Frequently Asked Questions
Who can join the NCT06535945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06535945 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06535945 currently recruiting?
Yes, NCT06535945 is actively recruiting participants. Contact the research team at loic.jacob@chu-rennes.fr for enrollment information.
Where is the NCT06535945 trial being conducted?
This trial is being conducted at Chambray-lès-Tours, France, Clichy, France, Lille, France, Lyon, France and 4 additional locations.
Who is sponsoring the NCT06535945 clinical trial?
NCT06535945 is sponsored by Rennes University Hospital. The principal investigator is Pauline HOUSSEL-DEBRY, MD at Rennes University Hospital. The trial plans to enroll 400 participants.