HALT : Influence of Human Albumin supplementation on kidney dysfunction after Liver Transplantation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Rennes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

26 Mar 2025 → ongoing

Decision date (initial)

2025-01-16

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Direction Générale de l'Offre de Soin (DGOS) - Programme Hospitalier de Recherche Clinique National

External identifiers

EU CT number

2024-514804-14-00

ClinicalTrials.gov

NCT06535945

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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 AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).

Secondary objectives 17

1. Occurrence and Severity stages of AKI during the first 7 days after liver transplantation
2. Hospital length of stay
3. Occurrence of calcineurin inhibitor induced neurotoxicity
4. occurence of calcineurin inhibitor withdraw
5. occurrence of postoperative infections
6. occurrence of acute graft rejection
7. occurrence of early graft dysfunction
8. duration of mechanical ventilation
9. reintubation rate
10. Intensive Care Unit length of stay
11. Intensive Care Unit readmission rate
12. All cause mortality
13. To study whether albumin administration will decrease the occurrence of lymphopenia after surgery
14. To study whether albumin administration will increase lymphocyte proliferation rate and decrease postoperative lymphocyte apoptosis
15. To study whether albumin administration will improve lymphocyte mitochondrial function
16. To study whether albumin administration will decrease postoperative immunosuppression
17. To study whether albumin administration will decrease postoperative inflammation

Conditions and MedDRA coding

Liver transplantation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. IC1 - Male and female patients equal or above 18 yrs old.
2. IC2 - Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).
3. IC3 - Capability of understanding the purpose and risks of the study.
4. IC4 - Written informed consent

Exclusion criteria 4

1. NIC1 - Fulminant hepatitis
2. NIC2 - Kidney injury at baseline (eGFR < 50 ml/min in MDRD) including hepatorenal syndrome
3. NIC3 - Use of an induction agent Basiliximab at liver transplantation
4. NIC4 - Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO criteria)

Secondary endpoints 17

1. Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO Criteria)
2. Hospital length of stay after liver transplantation defined by standardized checklist of discharged criteria
3. Postoperative calcineurin inhibitors-induced neurotoxicity at D28
4. Discontinuation of anticalcineurin inhibitor at D28.
5. Occurrence of postoperative infections at D28
6. Acute graft rejection (biopsy proved) at D28
7. Occurrence of early graft dysfunction (Olthoff criteria)
8. Duration of mechanical ventilation at D28
9. Occurrence of reintubation at D28
10. Duration of Intensive Care Unit length of stay up to D28
11. Occurence of Intensive Care Unit readmission after discharge of Intensive Care Unit up to D28
12. Mortality within the first 28 days following surgery
13. Defined as a lymphocyte count less than 1.2× 103 cells/µL
14. Using flow cytometry
15. Using the Seahorse analyzer measuring mitochondrial respiration
16. Measured using expression of HLA-DR on peripheral monocytes, plasmatic levels of IL-10, MDSC, RNA seq analysis on peripheral blood mononuclear cell
17. Plasmatic levels of IL-6

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Rennes

Sponsor organisation

Centre Hospitalier Universitaire De Rennes

Address

2 Rue Henri Le Guilloux

City

Rennes

Postcode

35000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

HOUSSEL-DEBRY pauline

Public contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

HOUSSEL-DEBRY pauline

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications