Albumin for Liver Cirrhosis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Anahita Rabiee MD MHS

Must be taking: Diuretics

Must not be taking: Other diuretics

Disqualifiers: Low GFR, Variceal bleeding, Heart failure, others

Prior Safety Data

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot change your oral diuretic regimen in the 7 days before starting the study. Some diuretics are not allowed, so you may need to adjust your medications accordingly.

What data supports the effectiveness of the drug albumin for liver cirrhosis?

Research shows that albumin can help manage complications in liver cirrhosis, such as reducing the risk of heart and circulation problems after fluid removal and improving response to other treatments for kidney issues. It also helps prevent fluid buildup and infections, making it a useful tool in managing cirrhosis. ^{1 2 3 4 5}

Is albumin safe for humans?

Albumin has been used safely in patients with liver cirrhosis to manage complications like fluid buildup and kidney issues. While its benefits are sometimes debated, it is generally considered safe for human use in these conditions. ^{1 4 5 6 7}

How does the drug albumin differ from other treatments for liver cirrhosis?

Albumin is unique in treating liver cirrhosis because it not only helps expand blood plasma volume but also has antioxidant and immune-modulating properties, which can prevent further liver damage and complications. It is particularly effective in managing ascites (fluid buildup in the abdomen) and preventing kidney issues in cirrhosis patients, offering benefits beyond traditional treatments. ^{1 4 5 8 9}

Research Team

Eligibility Criteria

This trial is for individuals with liver cirrhosis and ascites, which means they have a scarred liver and fluid buildup in the abdomen. The study aims to include those who also have swelling in their legs due to excess fluid.

Inclusion Criteria

I am 18 years old or older.

I have advanced liver disease with swelling in my abdomen and legs despite water pills.

Serum albumin of < 3.5 g/dL

Exclusion Criteria

I am taking certain water pills other than spironolactone or furosemide.

I am currently experiencing bleeding from enlarged veins.

I had an infection in my abdomen within the last month.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either albumin or placebo for one dose, followed by a 14-day washout period, then crossover to the alternate treatment

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in neurohumoral markers and kidney function after treatment

1 week

Treatment Details

Interventions

• Albumin (Plasma Expander)

Trial Overview The trial is testing whether infusing albumin (a protein) into the blood can help remove excess fluid more effectively than just saline solution in patients with liver issues. It's a small initial study comparing two groups: one receiving albumin and the other getting saline.

Participant Groups

Group I: Albumin first Active Control 2 Interventions

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.

Group II: Placebo first Placebo Group 2 Interventions

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

West Haven VA Medical Center West Haven, CT

Who Is Running the Clinical Trial?

Anahita Rabiee MD MHS

Lead Sponsor

Trials

1

Patients Recruited

20+

Grifols Shared Services North America Inc

Collaborator

Trials

1

Patients Recruited

20+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can albumin reduce the mortality of patients with cirrhosis and ascites? A meta-analysis of randomized controlled trials. Xu, T., Liu, W., Huang, R.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights About Albumin and Liver Disease. Carvalho, JR., Verdelho Machado, M.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Albumin Therapy Does Not Improve Short-Term Outcome in Hyponatremic Patients Hospitalized With Complications of Cirrhosis: Data From the ATTIRE Trial. China, L., Freemantle, N., Forrest, E., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis: Efficacy and safety of albumin in the prevention and treatment of complications in patients with cirrhosis. Leache, L., Gutiérrez-Valencia, M., Saiz, LC., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of albumin in cirrhosis: from a hospitalist's perspective. Walayat, S., Martin, D., Patel, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. Bai, Z., Wang, L., Wang, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis. Wong, YJ., Qiu, TY., Tam, YC., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[News for usage of albumin in patients with liver disease]. Cremonese, C., Uschner, FE., Trebicka, J.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of human albumin for the treatment of ascites in patients with liver cirrhosis: item of safety, facts, controversies and perspectives. Facciorusso, A., Nacchiero, MC., Rosania, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Can albumin reduce the mortality of patients with cirrhosis and ascites? A meta-analysis of randomized controlled trials. [2023]

2. Mexico pubmed.ncbi.nlm.nih.gov

New Insights About Albumin and Liver Disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Targeted Albumin Therapy Does Not Improve Short-Term Outcome in Hyponatremic Patients Hospitalized With Complications of Cirrhosis: Data From the ATTIRE Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Meta-analysis: Efficacy and safety of albumin in the prevention and treatment of complications in patients with cirrhosis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Role of albumin in cirrhosis: from a hospitalist's perspective. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of IV albumin for non-spontaneous bacterial peritonitis infection among patients with cirrhosis: A systematic review and meta-analysis. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[News for usage of albumin in patients with liver disease]. [2021]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The use of human albumin for the treatment of ascites in patients with liver cirrhosis: item of safety, facts, controversies and perspectives. [2022]