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Also known as Albumin infusion (25% albumin)
Albumin infusion · 1 trial · 2 indications
Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| Albumin infusion (25% albumin) | DRUG | Albumin 25 gram infusion |
| Normal Saline (0.9% NaCl) | DRUG | 100 cc of normal saline |
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 or...
Albumin infusion is being studied in cirrhosis, specifically in patients with cirrhosis and ascites. It is administered as a 25% albumin solution and is being evaluated for albumin assisted diuresis. The Phase 2 trial enrolls adults with cirrhosis and hepatic ascites, and it is not intended for healthy volunteers.
Albumin infusion is being developed by Grifols, S.A., which trades under the ticker GRFS. The company is sponsoring the Phase 2 clinical program evaluating the 25% albumin formulation in patients with cirrhosis and ascites.
Albumin infusion is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The ongoing Phase 2 study is currently recruiting participants and is designed to enroll 20 patients.
Albumin infusion is being evaluated in one active clinical trial, NCT06812390, titled Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites. The Phase 2 study is recruiting in the United States, has a target enrollment of 20 adults, and is randomized, double blind, and placebo controlled.
Yes, albumin infusion is also known as 25% albumin. The two names refer to the same product being studied by Grifols, S.A. in patients with cirrhosis and ascites.