NCT06812390 Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
| NCT ID | NCT06812390 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anahita Rabiee MD MHS |
| Condition | Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-02-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06812390 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06812390 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06812390 currently recruiting?
Yes, NCT06812390 is actively recruiting participants. Contact the research team at anahita.rabiee@va.gov for enrollment information.
Where is the NCT06812390 trial being conducted?
This trial is being conducted at West Haven, United States.
Who is sponsoring the NCT06812390 clinical trial?
NCT06812390 is sponsored by Anahita Rabiee MD MHS. The trial plans to enroll 20 participants.