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Droxidopa for Kidney Injury in Cirrhosis Patients

This study is testing if a medication called droxidopa can improve blood pressure in people with severe liver disease (decompensated cirrhosis) who are in the hospital with kidney problems (acute kidney injury). When you have cirrhosis and kidney injury, better blood pressure might help your kidneys recover. Droxidopa is a pill that could help raise blood pressure without needing intensive care. This study will compare droxidopa to a placebo (an inactive pill) in 75 hospitalized patients. You would take either droxidopa or the placebo for 28 days, and researchers will check your blood pressure and kidney function to see if droxidopa is effective and safe. The study is currently unclear on its recruitment status.

Study design
This is an interventional study comparing droxidopa to a placebo in 75 participants. It is a blinded study, meaning neither you nor your doctors will know if you are receiving droxidopa or the placebo.
What's involved
You would take oral capsules (either droxidopa or placebo) three times daily for 28 days, with the dose potentially adjusted. You must be hospitalized at Columbia University Irving Medical Center and able to take oral medications.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure will be measured from the start of the study up to 28 days. You will also be monitored for an additional 30 days after the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06937307

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Giuseppe Cullaro, MD
~75 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Droxidopa capsulesPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mean arterial pressure (MAP)
Measured over Baseline to 28 days

Conditions

Acute Kidney Injury
Cirrhosis
Decompensated Cirrhosis of Liver

Explore related trials

Acute Renal FailureDecompensated cirrhosis of liver

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Giuseppe Cullaro, MD, MAS · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Giuseppe Cullaro, MD, MAS
[email protected]
2123050914
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in mean arterial pressure (MAP)Baseline to 28 days

    The difference in mean arterial pressure between treatment groups over the 28-day treatment period, assessed using a linear mixed-effects model with fixed effects for treatment group and time, plus their interaction, while accounting for between-subject variability through random intercepts.