LIVER AKI: A trial to evaluate the efficacy of intravenous human albumin administration versus saline solution (NaCl 0.9%) in patients with decompensated cirrhosis and AKI 1B or grater.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10], Diseases [C] - Digestive System Diseases [C06]

Trial duration

21 Apr 2026 → ongoing

Decision date (initial)

2025-10-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III through a Health R+D+I Project with code PI24/01100.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To analyze the effect of HA versus (NaCl 0.9%) solution administration on the probability of AKI resolution among patients with decompensated cirrhosis and AKI 1B or greater.

Secondary objectives 8

1. Evaluate the effect of HA versus saline (NaCl 0.9%) administration on the 28-day survival in patients with AKI 1B or greater and decompensated cirrhosis
2. Assess the efficacy of HA versus saline (NaCl 0.9%) administration to improve AKI stage in patients with decompensate cirrhosis and AKI 1B or greater
3. Evaluate the impact of HA versus saline (NaCl 0.9%) administration in the requirements of RRT(Renal Replacement Therapy) among patients with AKI 1B or greater and decompensated cirrhosis.
4. Analyze the effect of HA versus saline (NaCl 0.9%) administration on changes in systemic inflammatory response in patients with AKI 1B or greater and decompensated cirrhosis.
5. Evaluate the effect of HA versus saline (NaCl 0.9%) administration on plasma and urine biomarkers related with tubular damage.
6. Study the effect of HA versus saline (NaCl 0.9%) administration in patients with AKI 1B or greater and decompensated cirrhosis on systemic hemodynamics, and the effect on vasoactive hormones.
7. Study the changes in echocardiographic parameters (E/E', ITV, among others).
8. Analyze the effect of HA versus saline (NaCl 0.9%) administration treatment-related adverse events during study period, evaluated as proportion of patients and severity.

Conditions and MedDRA coding

descompensated hepatic cirrosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 18 years old.
2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. (Cirrhosis of any etiology may be included).
3. Patients with AKI 1B or greater, defined according to EASL guidelines (EASL. J Hepatol 2018).
4. Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function. * A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. ** Sexual abstinence should only be used as a contraceptive method if it is in line with the subjects’ usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, postovulation methods) is not an acceptable method of contraception

Exclusion criteria 13

1. Time since AKI diagnosis > 24 hours.
2. Patients with AKI due to fluid loss. According to guidelines, these patients should receive crystalloid solutions (i.e. NaCl 0.9%) and will be excluded from the study. Fluid losses will be specifically assessed by an accurate anamnesis. If patient's diuretic treatment has been increased recently (within prior 2 weeks), or the patient had diarrhea before admission, patient will be considered that the AKI phenotype is pre-renal and will be excluded from the analysis.
3. Patients with AKI due to gastrointestinal bleeding with AKI 1B or greater, and hemoglobin < 7.0 g/dL. These patients can be included after 48 hours without rebleeding and Hb > 8.0 g/dL, and still present AKI 1B or greater.
4. Patients who had already received albumin at the time of inclusion/exclusion criteria assessment
5. Patients with Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate <60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate > 30 mg/24h; Albumin-to-creatinine ratio > 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging
6. Patients under renal replacement therapy, or with urgent criteria of RRT.
7. Patients with hepatocellular carcinoma beyond Milan criteria.
8. Patients with severe extrahepatic comorbidities, including congestive heart failure New York Heart Association Grade III/IV, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group 2 or higher.
9. Previous liver and/or kidney transplantation
10. Patients with current extra hepatic malignancies including solid tumors and hematologic disorders.
11. Patients included in other clinical trials in the month before inclusion
12. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
13. Refusal to give informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Analyze the effect of HA versus (NaCl 0.9%) administration on the probability of AKI resolution among patients with decompensated cirrhosis and AKI 1B or greater acute kidney injury (AKI) clinical efficacy of HA versus saline (NaCl 0.9%) administration in patients with AKI 1B or higher will be evaluated, defining AKI resolution as the percentage of patients with a decrease in serum creatinine levels < 0.3 mg/dL with respect to baseline serum creatinine, without the need for TRT.

Secondary endpoints 8

1. Survival rate at 28 days, considering liver transplantation as a competitive risk event
2. AKI improvement, defined as the percentage of patients who decrease at least 1 grade of AKI classification (from 3 to 2, from 2 to 1B, and from 1B to 1A or recovery), without the need for RRT
3. Proportion of patients requiring RRT In both groups
4. Changes from baseline in systemic inflammatory response, evaluated by measurement in a large array of plasma cytokine levels including, but not limited to TNFα, IL-6, IL8, IL-10, IL-1β, IFN-ɣ, G-CSF, VCAM, VEGF, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2) at visits 1, 2, 4, 5 and 6
5. Changes from baseline in different plasma and urine prognostic biomarkers including, but not only, copeptin, NGAL, PD-L1, L-FABP at visits 1, 2, 4, 5 and 6.
6. Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration and plasma copeptin at visits 1, 2, 4, 5 and 6,
7. Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28.
8. Proportion of patients and severity of treatment-related adverse events during the study period

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Sponsor organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Adria Juanola

Public contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Adria Juanola

Locations

1 EU/EEA country · 1 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 10 files

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

Application history

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