Using droxidopa to improve kidney function in patients with liver cirrhosis and kidney injury

Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury

This study is testing if an oral medication called droxidopa can help improve kidney function and blood pressure in hospitalized patients with liver cirrhosis and kidney injury.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Columbia University (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06937307 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of droxidopa, an oral medication, in increasing blood pressure and improving kidney function in hospitalized patients with decompensated cirrhosis and acute kidney injury. Participants will be randomly assigned to receive either droxidopa or a placebo for 28 days, followed by a 30-day monitoring period. The study aims to determine if droxidopa can safely enhance mean arterial pressure, which is crucial for kidney recovery in these patients. By comparing the outcomes between the two groups, researchers hope to identify a new treatment option for a serious complication of liver disease.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 18 and older with decompensated cirrhosis and acute kidney injury.

Not a fit: Patients with severe cardiovascular disease or those requiring renal replacement therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option to improve kidney recovery in patients with liver cirrhosis and acute kidney injury.

How similar studies have performed: While droxidopa has been FDA-approved for other conditions, its use in this specific patient population is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Ability to provide informed consent by subject or legally authorized representative
* Consent to blood and urine collection for biomarker analysis
* Ability to take oral medications
* At least 18 years of age
* Hospitalized at Columbia University Irving Medical Center
* Child-Pugh Score ≥ B7 cirrhosis (documented by imaging, biopsy, or clinical evidence)
* KDIGO Stage 1 AKI or greater, defined as:
* ≥0.3 mg/dL increase in serum creatinine within 48 hours OR
* ≥50% increase in serum creatinine from outpatient baseline
* Mean arterial pressure ≤85 mmHg averaged over 24 hours prior to randomization
* For women of childbearing potential: negative pregnancy test and agreement to use effective contraception

Exclusion Criteria:

* Serum creatinine \>4.0 mg/dL or current renal replacement therapy
* Age \>70 years
* Severe cardiovascular disease, including:
* Unstable angina
* Congestive heart failure requiring escalating medical therapy
* Symptomatic peripheral vascular disease
* Any cardiovascular condition deemed severe by investigator
* Active gastrointestinal bleeding, defined as requiring ≥ 2 units of packed red blood cells during the screening period
* Acute respiratory failure requiring more than 6L of Nasal Canula
* Use of medications that could interact with droxidopa including:
* MAOI inhibitors
* Norepinephrine reuptake inhibitors
* Other investigational drugs
* Pregnancy or breastfeeding
* Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart
* Prior liver transplantation

Where this trial is running

New York, New York

• Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Giuseppe Cullaro, MD, MAS — Columbia University
• Study coordinator: Giuseppe Cullaro, MD, MAS

Conditions: Acute Kidney Injury, Cirrhosis, Decompensated Cirrhosis of Liver, Decompensated Cirrhosis