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Albumin infusion

Phase 2

Cirrhosis | Small molecule | Gastrointestinal |Grifols, S.A.|Last Updated: Mar 11, 2025

Target and mechanism

ModalitySmall molecule

Also known as Albumin infusion (25% albumin)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Albumin infusion · 1 trial · 2 indications

Phase 2 1
NCT06812390Albumin Assisted Diuresis in Patients with Cirrhosis and AscitesCirrhosis
RECRUITING20 Analytics
PHASE2RECRUITING
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
CirrhosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in fractional excretion of sodium (FENa)
6 hours (baseline vs hour 6 after albumin vs placebo administration)

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

Secondary Endpoints

Changes in neuro hormonal markers
6 hours and 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

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

Interventions

NameTypeDescription
Albumin infusion (25% albumin)DRUGAlbumin 25 gram infusion
Normal Saline (0.9% NaCl)DRUG100 cc of normal saline
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Frequently asked questions about Albumin infusion

What is Albumin infusion used for in cirrhosis?

Albumin infusion (25% albumin) is an investigational therapy being studied for cirrhosis, specifically for patients with cirrhosis and ascites. It is being evaluated in a Phase 2 clinical trial to assist diuresis in this patient population. The drug is administered as an infusion and is currently in clinical development.

Who makes Albumin infusion?

Albumin infusion is being developed by Grifols, S.A., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol GRFS. Grifols is conducting a Phase 2 clinical trial to evaluate the safety and efficacy of Albumin infusion in patients with cirrhosis and ascites.

What phase is Albumin infusion in?

Albumin infusion is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is recruiting patients with cirrhosis and ascites to assess the drug's ability to assist diuresis in this condition.

What clinical trials is Albumin infusion in?

Albumin infusion is being studied in a Phase 2 clinical trial with the identifier NCT06812390, titled "Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites." This randomized, double-blind, placebo-controlled trial is recruiting 20 participants in the United States. The study is currently active and enrolling patients aged 18 years and older.

Is Albumin infusion the same as Albumin infusion (25% albumin)?

Yes, Albumin infusion is also known as Albumin infusion (25% albumin). The 25% formulation refers to the concentration of albumin in the solution. This formulation is being investigated in the Phase 2 clinical trial for cirrhosis and ascites, where it is administered to assist diuresis.

What does Albumin infusion target?

Albumin infusion is a small molecule therapy that works by supplementing albumin levels in the body. In patients with cirrhosis and ascites, albumin infusion is used to help manage fluid accumulation by assisting diuresis. The trial is biomarker-selected, indicating that patient selection may be based on specific biological markers.