Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation (HALT)

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)).

Study Overview

• Status: Recruiting
• Conditions: Liver Transplantation; Acute Kidney Injury
• Intervention / Treatment: Drug: Albumin administration

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Loïc JACOB; Phone Number: +33299282555; Email: loic.jacob@chu-rennes.fr

Study Locations

• France
  • Chambray-lès-Tours, France, 37170
    • Recruiting
    • 08_CHRU de Tours Hôpital Trousseau
    • Principal Investigator: Ephrem SALAME, MD
    • Contact: Ephrem SALAME, MD; Phone Number: 05 50 05 65 68; Email: e.salame@chu-tours.fr
  • Clichy, France, 92110
    • Recruiting
    • 03_APHP Hôpital Beaujon
    • Contact: Claire FRANCOZ, MD; Phone Number: 04 73 75 22 01; Email: claire.francoz@aphp.fr
    • Principal Investigator: Claire FRANCOZ, MD
    • Sub-Investigator: Emmanuel WEISS, MD
  • Lille, France, 59000
    • Not yet recruiting
    • 04_CHU de Lille Hôpital Huriez
    • Principal Investigator: Sébastien DHARANCY, MD
    • Contact: Sébastien DHARANCY, MD; Phone Number: 02 98 34 73 00; Email: sebastien.dharancy@chru-lille.fr
    • Sub-Investigator: Gilles LEBUFFE, MD
  • Lyon, France, 69004
    • Recruiting
    • 05_HCL Hôpital de la Croix Rousse
    • Sub-Investigator: CELINE GUICHON, MD
    • Principal Investigator: Marie-Charlotte Delignette, MD
    • Contact: Marie-Charlotte DELIGNETTE, MD; Phone Number: +33 4 26 10 90 70; Email: marie-charlotte.delignette@chu-lyon.fr
  • Montpellier, France, 34295
    • Recruiting
    • 06_CHU de Montpellier Hôpital St Eloi
    • Principal Investigator: Georges Philippe PAGEAUX, MD
    • Sub-Investigator: Clément MONET, MD
    • Contact: Georges Philippe PAGEAUX, MD; Phone Number: 02 31 06 46 17; Email: gp-pageaux@chu-montpellier.fr
  • Pessac, France, 33604
    • Recruiting
    • 02_CHU de Bordeaux - Hôpital Haut Leveque
    • Contact: Jean Baptiste HIRIART, MD; Phone Number: 0130754040; Email: jean-baptiste.hiriart@chu-bordeaux.fr
    • Principal Investigator: Antoine DEWITTE, MD
    • Sub-Investigator: Jean Baptiste HIRIART, MD
  • Rennes, France, 35000
    • Recruiting
    • 01_CHU de Rennes Hôpital Pontchaillou
    • Contact: Pauline HOUSSEL-DEBRY, MD; Phone Number: 0299257540; Email: pauline.houssel-debry@chu-rennes.fr
    • Principal Investigator: Jean-Marc TADIE, MD
    • Sub-Investigator: Pauline HOUSSEL-DEBRY, MD
  • Villejuif, France, 94804
    • Not yet recruiting
    • 09_APHP Hôpital Paul Brousse
    • Contact: Philippe Ichaï, MD; Phone Number: 03 20 78 49 01; Email: philippe.ichai@aphp.fr
    • Principal Investigator: Philippe Ichaï, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 g/L or below; Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below	Drug: Albumin administration; when albumin serum concentration is at 30 g/L or below
Active Comparator: 20 g/L or below; receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below	Drug: Albumin administration; when albumin serum concentration is at 30 g/L or below

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kindey Injury at Day 7	To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (=30 g/L) for five days diminishes rate of Acute Kindey Injury at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).	7 days after liver transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation	Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation	7 days after liver transplantation
hospital length of stay	hospital length of stay	28 days
occurrence of calcineurin inhibitor induced neurotoxicity	occurrence of calcineurin inhibitor induced neurotoxicity	28 days
occurence of calcineurin inhibitor withdraw	occurence of calcineurin inhibitor withdraw	28 days
occurrence of postoperative infections	occurrence of postoperative infections	28 days
occurrence of acute graft rejection	occurrence of acute graft rejection	28 days
occurrence of early graft dysfunction	occurrence of early graft dysfunction	28 days
duration of mechanical ventilation	duration of mechanical ventilation	28 days
reintubation rate	reintubation rate	28 days
Intensive Care Unit length of stay	Intensive Care Unit length of stay	28 days
Intensive Care Unit readmission rate	Intensive Care Unit readmission rate	28 days
All cause mortality	All cause mortality	28 days

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Pauline HOUSSEL-DEBRY, MD, CHU Rennes

Publications and helpful links

Helpful Links

• European Medicines Agency Registry

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): April 26, 2028
• Study Completion (Estimated): April 26, 2028

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Transplantation; Acute Kidney Injury; Liver; Albumin
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 35RC22_9739_HALT; 2024-514804-14-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No