Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation

NCT ID: NCT06535945

Last Updated: 2025-12-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2028-04-26

Brief Summary

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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)).

Detailed Description

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Conditions

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Liver Transplantation Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Albumin administration

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Albumin administration

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

03_APHP Hôpital Beaujon

Clichy, , France

Site Status RECRUITING

04_CHU de Lille Hôpital Huriez

Lille, , France

Site Status NOT_YET_RECRUITING

05_HCL Hôpital de la Croix Rousse

Lyon, , France

Site Status RECRUITING

06_CHU de Montpellier Hôpital St Eloi

Montpellier, , France

Site Status RECRUITING

02_CHU de Bordeaux - Hôpital Haut Leveque

Pessac, , France

Site Status RECRUITING

01_CHU de Rennes Hôpital Pontchaillou

Rennes, , France

Site Status RECRUITING

09_APHP Hôpital Paul Brousse

Villejuif, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Loïc JACOB

Role: CONTACT

+33299282555

Facility Contacts

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Ephrem SALAME, MD

Role: primary

05 50 05 65 68

Claire FRANCOZ, MD

Role: primary

04 73 75 22 01

Sébastien DHARANCY, MD

Role: primary

02 98 34 73 00

Marie-Charlotte DELIGNETTE, MD

Role: primary

+33 4 26 10 90 70

Georges Philippe PAGEAUX, MD

Role: primary

02 31 06 46 17

Jean Baptiste HIRIART, MD

Role: primary

0130754040

Pauline HOUSSEL-DEBRY, MD

Role: primary

0299257540

Philippe Ichaï, MD

Role: primary

03 20 78 49 01

Related Links

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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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