Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
NCT ID: NCT06535945
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
400 participants
INTERVENTIONAL
2025-03-26
2028-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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30 g/L or below
Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below
Albumin administration
when albumin serum concentration is at 30 g/L or below
20 g/L or below
receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below
Albumin administration
when albumin serum concentration is at 30 g/L or below
Interventions
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Albumin administration
when albumin serum concentration is at 30 g/L or below
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Pauline HOUSSEL-DEBRY, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Locations
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08_CHRU de Tours Hôpital Trousseau
Chambray-lès-Tours, , France
03_APHP Hôpital Beaujon
Clichy, , France
04_CHU de Lille Hôpital Huriez
Lille, , France
05_HCL Hôpital de la Croix Rousse
Lyon, , France
06_CHU de Montpellier Hôpital St Eloi
Montpellier, , France
02_CHU de Bordeaux - Hôpital Haut Leveque
Pessac, , France
01_CHU de Rennes Hôpital Pontchaillou
Rennes, , France
09_APHP Hôpital Paul Brousse
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Related Links
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European Medicines Agency Registry
Other Identifiers
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2024-514804-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
35RC22_9739_HALT
Identifier Type: -
Identifier Source: org_study_id
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