Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

NCT06812390 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 1791319680800001061
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.

Conditions

Cirrhosis; Ascites Hepatic

Keywords

albumin; cirrhosis; ascites; diuresis

Outcome Measures

Primary Outcomes (1)

• Change in fractional excretion of sodium (FENa)

  Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo

  6 hours (baseline vs hour 6 after albumin vs placebo administration)

Secondary Outcomes (1)

• Changes in neuro hormonal markers

  6 hours and 24 hours

Study Arms (2)

Albumin first

ACTIVE COMPARATOR

Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose.

Placebo first

PLACEBO COMPARATOR

Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose.

Drug: Albumin infusion (25% albumin); Drug: Normal Saline (0.9% NaCl)

Interventions

Albumin infusion (25% albumin) DRUG

Albumin 25 gram infusion

Placebo first

Normal Saline (0.9% NaCl) DRUG

100 cc of normal saline

Placebo first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration
• Serum albumin of \< 3.5 g/dL
• Age \>=18 years old

You may not qualify if:

• Patients with GFR \< 30mL/min/1.73 m2
• Changes in oral diuretic regimen in the past 7 days (\*\*patients can enter the study after 7 days of the change)
• Large Volume paracentesis (LVP) in the past 7 days (\*\*patients can enter the study after 7 days)
• Albumin infusion within the previous 14 days (\*\* patients can enter the study after 14 days)
• Spontaneous Bacterial Peritonitis in the past month
• Active variceal bleeding
• Current Hepatic encephalopathy (\>= Grade 2 based on West Haven criteria)
• Co-administration of other diuretics such as Hydrochlorothiazide (amiloride or eplerenone in place of spironolactone, and Bumex/Torsemide in place of furosemide are acceptable)
• Hypotension (Mean Arterial Pressure \<65 mmHg, Systolic Blood pressure \<90 mmHg)
• Severe hyponatremia (Sodium \<125 mEq/L)
• previous diagnosis of overt heart failure (systolic EF \< 50%)
• Baseline oxygen requirement
• Hypersensitivity to albumin preparations

Sponsors & Collaborators

• Anahita Rabiee MD MHS: lead
• Grifols Shared Services North America Inc: collaborator

Study Sites (1)

West Haven VA Medical Center

West Haven, Connecticut, 06516, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Albumins; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Anahita Rabiee, MD, MHS

CONTACT

203-932-5711; anahita.rabiee@va.gov

Lynn F. Buchwalder, M.S.

CONTACT

203-932-5711; Lynn.Buchwalder@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Hepatologist, MD, MHS

Model Details: Proof of concept, randomized, cross over, double-blind placebo-controlled study

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 6, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)