Taking people in United StatesPhase 2

Droxidopa to raise blood pressure in cirrhosis with kidney injury

Tests droxidopa in hospital patients with cirrhosis and kidney injury.

Key facts

Who runs it: Giuseppe Cullaro, MD
Where: New York, United StatesSee the site
Trial code: NCT06937307
Registry title: Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
Status: Recruiting
Phase: Phase 2
People taking part: 75 people, planned
Started: 27 May 2025
Expected to end: 31 Dec 2028
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Droxidopa capsules
Placebo
Record updated: 19 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in hospital at Columbia University Irving Medical Center with advanced liver cirrhosis, sudden kidney injury and low blood pressure. They will take droxidopa or a placebo (dummy pill) for 28 days.

Age: 18 to 70 years
Sex: All sexes
Disease stage: Cirrhosis with a Child-Pugh Score of B7 or higher. Sudden kidney injury (AKI) of KDIGO Stage 1 or greater: serum creatinine up ≥0.3 mg/dL (27 µmol/L) within 48 hours, or up ≥50% from the outpatient baseline. Mean arterial pressure ≤85 mmHg averaged over the 24 hours before the study group is picked.
Earlier treatment: People who had a liver transplant before cannot join. People on dialysis or other kidney replacement therapy cannot join. People taking MAOI inhibitors, norepinephrine reuptake inhibitors or other investigational drugs cannot join.
Biomarker or test result: Serum creatinine must not be above 4.0 mg/dL (354 µmol/L).

Main reasons for not taking part

Severe heart or blood vessel disease, such as unstable angina or worsening heart failure
Active bleeding in the gut needing ≥ 2 units of packed red blood cells during screening
Breathing failure needing more than 6L of oxygen through the nose
Pregnancy or breastfeeding
Upper blood pressure ≥ 180 mmHg or lower blood pressure ≥ 120 mmHg on two readings 1 minute apart

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

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

Who cannot take part

Use of medications that could interact with droxidopa including:
MAOI inhibitors
Norepinephrine reuptake inhibitors
Other investigational drugs
Prior liver transplantation
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
Serum creatinine >4.0 mg/dL or current renal replacement therapy
Age >70 years
Pregnancy or breastfeeding
Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

Where in United States

Columbia University Irving Medical CenterNew York, United StatesContact: Giuseppe Cullaro, MD, MASTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

DroxidopaTreatment being tested
Participants in this arm will receive oral droxidopa capsules at an initial dose of 100 mg three times daily, titrated in 100 mg increments every 24 hours based on blood pressure response and tolerability, up to a maximum dose of 300 mg three times daily. Doses will be given approximately 4 hours apart during daytime hours for a total treatment duration of 28 days.
Treatment: Droxidopa capsules
PlaceboPlacebo, for comparison
Participants in this arm will receive matched placebo capsules following the same dosing schedule and titration protocol as the experimental arm. Placebo capsules will be identical in appearance to droxidopa capsules with the same over-encapsulation process to maintain blinding. Doses will be given three times daily for a total treatment duration of 28 days.