Liver TransplantationPhase 4HALTNCT06535945
Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
A Phase 4 study testing Albumin administration in people with Liver Transplantation and Acute Kidney Injury, run by Rennes University Hospital at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Acute Kidney Injury
- What is being tested?
- Albumin administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 8 sitesFrance
- Study dates
- 26 Mar 2025to 26 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
08_CHRU de Tours Hôpital Trousseau
Chambray-lès-Tours, 37170
Ephrem SALAME, MD, 05 50 05 65 68, e.salame@chu-tours.fr
Ephrem SALAME, MD
- Recruiting
03_APHP Hôpital Beaujon
Clichy, 92110
Claire FRANCOZ, MD, 04 73 75 22 01, claire.francoz@aphp.fr
Claire FRANCOZ, MD
- Recruiting
04_CHU de Lille Hôpital Huriez
Lille, 59000
Sébastien DHARANCY, MD, 02 98 34 73 00, sebastien.dharancy@chru-lille.fr
Sébastien DHARANCY, MD
- Recruiting
05_HCL Hôpital de la Croix Rousse
Lyon, 69004
Marie-Charlotte DELIGNETTE, MD, +33 4 26 10 90 70, marie-charlotte.delignette@chu-lyon.fr
Marie-Charlotte DELIGNETTE, MD
- Recruiting
06_CHU de Montpellier Hôpital St Eloi
Montpellier, 34295
Georges Philippe PAGEAUX, MD, 02 31 06 46 17, gp-pageaux@chu-montpellier.fr
Georges Philippe PAGEAUX, MD
- Recruiting
02_CHU de Bordeaux - Hôpital Haut Leveque
Pessac, 33604
Jean Baptiste HIRIART, MD, 0130754040, jean-baptiste.hiriart@chu-bordeaux.fr
Jean Baptiste HIRIART, MD
- Recruiting
01_CHU de Rennes Hôpital Pontchaillou
Rennes, 35000
Pauline HOUSSEL-DEBRY, MD, 0299257540, pauline.houssel-debry@chu-rennes.fr
Pauline HOUSSEL-DEBRY, MD
- Recruiting
09_APHP Hôpital Paul Brousse
Villejuif, 94804
Philippe Ichaï, MD, 03 20 78 49 01, philippe.ichai@aphp.fr
Philippe Ichaï, MD
About this study
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)).
- Conditions
- Liver Transplantation, Acute Kidney Injury
- Being tested
- Albumin administration
- Keywords
- Liver, Transplantation, Albumin, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin administrationDrug
when albumin serum concentration is at 30 g/L or below
| Study group | Role | What they receive |
|---|---|---|
| 30 g/L or below | Experimental | Receive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below Receives: 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 Receives: Drug: Albumin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 7 days after liver transplantation
Secondary outcomes (12)
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
Measured: 7 days after liver transplantation
hospital length of stay
hospital length of stay
Measured: 28 days
occurrence of calcineurin inhibitor induced neurotoxicity
occurrence of calcineurin inhibitor induced neurotoxicity
Measured: 28 days
occurence of calcineurin inhibitor withdraw
occurence of calcineurin inhibitor withdraw
Measured: 28 days
occurrence of postoperative infections
occurrence of postoperative infections
Measured: 28 days
occurrence of acute graft rejection
occurrence of acute graft rejection
Measured: 28 days
occurrence of early graft dysfunction
occurrence of early graft dysfunction
Measured: 28 days
duration of mechanical ventilation
duration of mechanical ventilation
Measured: 28 days
reintubation rate
reintubation rate
Measured: 28 days
Intensive Care Unit length of stay
Intensive Care Unit length of stay
Measured: 28 days
Intensive Care Unit readmission rate
Intensive Care Unit readmission rate
Measured: 28 days
All cause mortality
All cause mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start26 Mar 2025
- Primary completion26 Apr 2028 (estimated)
- Study completion26 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pauline HOUSSEL-DEBRY, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535945
- Sponsor's protocol ID
- 35RC22_9739_HALT
- Other IDs
- 2024-514804-14-00
- Acronym
- HALT
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Human Albumin Supplementation on Kidney Dysfunction After Liver Transplantation
- ClinicalTrials.gov ID
- NCT06535945
- Acronym / sponsor ID
- HALT / 35RC22_9739_HALT
- Conditions
- Liver Transplantation, Acute Kidney Injury
- Keywords
- Liver, Transplantation, Albumin, Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 26 Apr 2028 (estimated)
- Study completion
- 26 Apr 2028 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 g/L or below | Experimental | Drug: Albumin administrationReceive Human Albumin 20% Solution when albumin serum concentration is at 30 g/L or below |
| 20 g/L or below | Active comparator | Drug: Albumin administrationreceive Human Albumin 20% Solution when albumin serum concentration is at 20 g/L or below |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin administrationwhen albumin serum concentration is at 30 g/L or below | Drug | 20 g/L or below, 30 g/L or below |
Primary outcome
Acute Kindey Injury at Day 7
Time frame: 7 days after liver transplantation
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)).
12 secondary outcomes
Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation
Time frame: 7 days after liver transplantation
hospital length of stay
Time frame: 28 days
occurrence of calcineurin inhibitor induced neurotoxicity
Time frame: 28 days
occurence of calcineurin inhibitor withdraw
Time frame: 28 days
occurrence of postoperative infections
Time frame: 28 days
occurrence of acute graft rejection
Time frame: 28 days
occurrence of early graft dysfunction
Time frame: 28 days
duration of mechanical ventilation
Time frame: 28 days
reintubation rate
Time frame: 28 days
Intensive Care Unit length of stay
Time frame: 28 days
Intensive Care Unit readmission rate
Time frame: 28 days
All cause mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- European Medicines Agency RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pauline HOUSSEL-DEBRY, MD principal investigator
Rennes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albumin administration in people with Liver Transplantation and Acute Kidney Injury, run by Rennes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loïc JACOB (+33299282555, loic.jacob@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kindey Injury at Day 7 (time frame: 7 days after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.