ALBUMINUS: Dose reduction of human albumin during large-volume paracentesis in patients with cirrhosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-06-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The primary objective of this study is to demonstrate that low-dose IV HA (4 g/L) is non-inferior to the standard 8 g/L regimen in preventing future liver-related decompensation events, defined as spontaneous bacterial peritonitis, hepatorenal syndrome - acute kidney injury (HRS-AKI), variceal bleeding, and hepatic encephalopathy, in patients with cirrhosis undergoing LVP.

Secondary objectives 5

1. To evaluate the incidence of hypotension, hyponatremia, and renal complications. Renal complications include: a. new-onset AKI, defined as a 26,5 μmol rise in creatinine <48h; and b. progression of existing kidney disease, defined as a ≥25% reduction in estimated glomerular filtration rate [eGFR]).
2. To assess the frequency of fluid overload events and other adverse events.
3. To determine the impact on the overall quality of life.
4. To conduct a cost-effectiveness analysis, including measuring quality-adjusted life years (QALYs).
5. To explore the effects on time-to-decompensation, changes in liver disease severity scores, transjugular intrahepatic portosystemic shunt (TIPS)-free survival, transplant-free survival, and overall survival.

Conditions and MedDRA coding

liver cirrhosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. • Age ≥ 18 years.
2. • Portal hypertension-driven ascites due to cirrhosis requiring LVP.
3. • Documented informed consent to participate.

Exclusion criteria 8

1. • New-onset AKI before screening and randomization, defined as an increase in serum creatinine of ≥ 26.5 μmol/L within 48 hours, or an increase of serum creatinine to ≥ 1.5 times the baseline creatinine level within 7 days.
2. • Hemodynamic instability, defined as a mean arterial pressure < 60 mmHg.
3. • Systemic infection, defined as documentation or strong clinical suspicion of an infectious source.
4. • TIPS procedure in past medical history or planned.
5. • Patients with advanced hepatocellular carcinoma (HCC) stage BCLC-B or higher.
6. • Variceal bleeding within one week prior to presentation.
7. • Acute-on-chronic liver failure (ACLF) defined as a chronic liver failure consortium organ failure score of 8 or higher (representing ≥ 2 (out of 6) failing organ systems), using the CLIF-C organ failure score.
8. • Patients who have already been included in the study previously.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome measure will be described as the proportion of patients with at least one overt liver-related decompensation events between randomization and 52 weeks. These events include: • Spontaneous bacterial peritonitis • HRS-AKI • Variceal bleeding • Hepatic encephalopathy Each of these decompensation events are defined according to international criteria, as described in the protocol.

Secondary endpoints 15

1. The incidence of new-onset AKI, defined as a 26,5 μmol rise in creatinine <48h, leading to contact with hospital and/or hospitalization, assessed per LVP.
2. Chronic kidney disease (CKD)-stage progression, leading to contact with hospital and/or hospitalization, monitored during the evaluation moments.
3. ≥ 25% reduction in eGFR, leading to contact with hospital and/or hospitalization assessed per LVP.
4. Hyponatremia (< 130mmol/L), leading to contact with hospital and/or hospitalization assessed per LVP
5. Hemodynamic instability (mean arterial pressure < 60mmHg), leading to contact with hospital and/or hospitalization assessed per LVP.
6. Development of fluid overload related events (pulmonary edema leading to respiratory dysfunction), leading to contact with hospital and/or hospitalization assessed per LVP.
7. Adverse events as reported by the healthcare provider, leading to contact with hospital and/or hospitalization assessed per LVP.
8. Quality of life, measured with the EuroQol-5 Dimensions-5 Levels questionnaire (EQ-5D-5L) monitored during the evaluation moments.
9. Medical costs, measured with iMedical Consumption Questionnaire (iMCQ), monitored during the evaluation moments.
10. Productivity loss, measured with iProductivity Cost Questionnaire (iPCQ), monitored during the evaluation moments.
11. Time-to-decompensation event, monitored during the evaluation moments.
12. Change in liver disease severity scores (Model For End-Stage Liver Disease (MELD) score, Child-Pugh score), monitored during the evaluation moments.
13. Transjugular intrahepatic portosystemic shunt-free survival, monitored during the evaluation moments.
14. Transplant-free survival, monitored during the evaluation moments.
15. Overall survival, monitored during the evaluation moments.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Marten Lantinga

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Marten Lantinga

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

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

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