CirrhosisPhase 2NCT06812390
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
A Phase 2 study testing Albumin infusion (25% albumin) and Normal Saline (0.9% NaCl) in people with Cirrhosis and Ascites Hepatic, run by Anahita Rabiee MD MHS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Ascites Hepatic
- What is being tested?
- Albumin infusion (25% albumin) and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Haven VA Medical Center
West Haven, Connecticut, 06516
Anahita Rabiee, MD, MHS, 203-932-5711 ext. ext.1-5871, anahita.rabiee@va.gov
Lynn F Buchwalder, M.S., 203-932-5711, Lynn.Buchwalder@va.gov
About this study
Official title: Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial
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
- Being tested
- Albumin infusion (25% albumin), Normal Saline (0.9% NaCl)
- Keywords
- albumin, cirrhosis, ascites, diuresis
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin infusion (25% albumin)Drug
Albumin 25 gram infusion
Normal Saline (0.9% NaCl)Drug
100 cc of normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albumin infusion (25% albumin); Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fractional excretion of sodium (FENa)
Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo
Measured: 6 hours (baseline vs hour 6 after albumin vs placebo administration)
Secondary outcomes (1)
Changes in neuro hormonal markers
Changes in neuro hormonal markers including norepinephrine, renin, aldosterone
Measured: 6 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start28 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Proof of concept, randomized, cross over, double-blind placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anahita Rabiee MD MHS
- Sponsor type
- US federal agency
- Collaborators
- Grifols Shared Services North America, Inc.
- Responsible party
- Sponsor-investigator, Anahita Rabiee MD MHS, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812390
- Sponsor's protocol ID
- 1791319
- Other IDs
- 680800001061
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT06812390
- Acronym / sponsor ID
- 1791319
- Conditions
- Cirrhosis, Ascites Hepatic
- Keywords
- albumin, cirrhosis, ascites, diuresis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anahita Rabiee MD MHSUS federal agency
- Collaborators
- Grifols Shared Services North America, Inc.
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Proof of concept, randomized, cross over, double-blind placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Albumin infusion (25% albumin), Drug: Normal Saline (0.9% NaCl)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin infusion (25% albumin)Albumin 25 gram infusion | Drug | Placebo first |
| Normal Saline (0.9% NaCl)100 cc of normal saline | Drug | Placebo first |
Primary outcome
Change in fractional excretion of sodium (FENa)
Time frame: 6 hours (baseline vs hour 6 after albumin vs placebo administration)
Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo
1 secondary outcome
Changes in neuro hormonal markers
Time frame: 6 hours and 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin infusion (25% albumin) and Normal Saline (0.9% NaCl) in people with Cirrhosis and Ascites Hepatic, run by Anahita Rabiee MD MHS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anahita Rabiee, MD, MHS (203-932-5711 ext. ext.1-5871, anahita.rabiee@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fractional excretion of sodium (FENa) (time frame: 6 hours (baseline vs hour 6 after albumin vs placebo administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.