Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation

Last updated: March 26, 2025
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Liver Transplantation

Renal Failure

Kidney Failure

Treatment

Albumin administration

Clinical Study ID

NCT06535945
35RC22_9739_HALT
2024-514804-14-00
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Male and female subjects equal or above 18 yrs old.

  • Recipients of primary liver allografts from a deceased donor (including aftercardiac death) and as a single organ (liver only).

  • Capability of understanding the purpose and risks of the study.

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Fulminant hepatitis

  • Kidney injury at baseline (Estimated Glomerular Filtration Rate < 50 ml/min inModification 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

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Albumin administration
Phase: 4
Study Start date:
March 26, 2025
Estimated Completion Date:
April 26, 2028

Connect with a study center

  • 08_CHRU de Tours Hôpital Trousseau

    Chambray-les-tours, 37170
    France

    Site Not Available

  • 03_APHP Hôpital Beaujon

    Clichy, 92110
    France

    Site Not Available

  • 04_CHU de Lille Hôpital Huriez

    Lille, 59000
    France

    Site Not Available

  • 05_HCL Hôpital de la Croix Rousse

    Lyon, 69004
    France

    Site Not Available

  • 06_CHU de Montpellier Hôpital St Eloi

    Montpellier, 34295
    France

    Site Not Available

  • 07_APHP Hôpital La Pitié Salpêtrière

    Paris, 75651
    France

    Site Not Available

  • 02_CHU de Bordeaux - Hôpital Haut Leveque

    Pessac, 33604
    France

    Site Not Available

  • 01_CHU de Rennes Hôpital Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • 09_APHP Hôpital Paul Brousse

    Villejuif, 94804
    France

    Site Not Available

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