Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
Giuseppe Cullaro, MD
75 participants
May 27, 2025
INTERVENTIONAL
Conditions
Summary
This study tests whether a medication called droxidopa can help improve blood flow to the kidneys in people with liver cirrhosis who develop kidney problems while in the hospital. When someone with cirrhosis experiences kidney injury, having better blood pressure can help their kidneys recover. Droxidopa is an oral medication that may help raise blood pressure without requiring intensive care or invasive treatments. The study will compare droxidopa to a placebo (inactive pill) in 75 people hospitalized with cirrhosis and kidney injury. Participants will take either droxidopa or placebo pills for 28 days and be monitored for an additional 30 days. Researchers will measure changes in blood pressure and kidney function to determine if droxidopa is effective and safe for these patients. This research could identify a new treatment option for a serious complication of liver disease.
Eligibility
Inclusion Criteria11
- 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 Criteria16
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Droxidopa is an oral synthetic amino acid that is directly metabolized to norepinephrine by dopa-decarboxylase. It will be administered at an initial dose of 100 mg three times daily, titrated in 100 mg increments every 24 hours based on blood pressure response, up to a maximum of 300 mg three times daily. Doses will be given approximately 4 hours apart during daytime hours, at least 3 hours apart, with a maximum total daily dose of 900 mg. The treatment duration is 28 days. The drug will be over-encapsulated using opaque capsules to maintain the double-blind design.
Matching placebo capsules containing microcrystalline cellulose (from Millipore Sigma) will be over-encapsulated using identical opaque capsules to maintain blinding. Placebo will be administered following the same schedule as the active treatment: three times daily with the same titration protocol based on blood pressure response, for a treatment duration of 28 days. The Columbia University Research Pharmacy will perform over-encapsulation of both active drug and placebo to ensure they are identical in appearance.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06937307