NCT06535945

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)).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
24mo left

Started Mar 2025

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Mar 2025Apr 2028

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2028

Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

July 30, 2024

Last Update Submit

December 2, 2025

Conditions

Liver TransplantationAcute Kidney Injury

Keywords

LiverTransplantationAlbuminAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

    28 days

  • occurrence of calcineurin inhibitor induced neurotoxicity

    28 days

  • occurence of calcineurin inhibitor withdraw

    28 days

  • occurrence of postoperative infections

    28 days

  • +7 more secondary outcomes

Study Arms (2)

30 g/L or below

EXPERIMENTAL

Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below

Drug: Albumin administration

20 g/L or below

ACTIVE COMPARATOR

receive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below

Drug: Albumin administration

Interventions

Albumin administrationDRUG

when albumin serum concentration is at 30 g/L or below

20 g/L or below30 g/L or below

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

08_CHRU de Tours Hôpital Trousseau

Chambray-lès-Tours, 37170, France

RECRUITING

03_APHP Hôpital Beaujon

Clichy, 92110, France

RECRUITING

04_CHU de Lille Hôpital Huriez

Lille, 59000, France

NOT YET RECRUITING

05_HCL Hôpital de la Croix Rousse

Lyon, 69004, France

RECRUITING

06_CHU de Montpellier Hôpital St Eloi

Montpellier, 34295, France

RECRUITING

02_CHU de Bordeaux - Hôpital Haut Leveque

Pessac, 33604, France

RECRUITING

01_CHU de Rennes Hôpital Pontchaillou

Rennes, 35000, France

RECRUITING

09_APHP Hôpital Paul Brousse

Villejuif, 94804, France

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Pauline HOUSSEL-DEBRY, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïc JACOB

CONTACT

+33299282555loic.jacob@chu-rennes.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

March 26, 2025

Primary Completion (Estimated)

April 26, 2028

Study Completion (Estimated)

April 26, 2028

Last Updated

December 9, 2025

Record last verified: 2025-12

Locations

FR(8)