Recruiting

Phase 2

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

Sponsor:

Giuseppe Cullaro, MD

Code:

NCT06937307

Conditions

Acute Kidney Injury

Cirrhosis

Decompensated Cirrhosis of Liver

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Droxidopa capsules

Placebo

Study Details

Brief 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.

Conditions

Acute Kidney Injury

Cirrhosis

Decompensated Cirrhosis of Liver

Study ID

NCT06937307

Start date

May 27, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Droxidopa

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.

placebo comparator: Placebo

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.

Interventions

Droxidopa capsules

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.

Placebo

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.

Primary outcome measure

Change in mean arterial pressure (MAP) [ Time Frame: Baseline to 28 days ]

Central Contacts and Locations

Central contacts

Giuseppe Cullaro, MD, MAS

2123050914 gc2576@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Giuseppe Cullaro, MD, MAS

2123050914 gc2576@cumc.columbia.edu

Theresa Lukose Research Director, PharmD

212-305-3839 tt2103@cumc.columbia.edu

Principal Investigator:

Giuseppe Cullaro, MD, MAS

More Information

Sponsor

Giuseppe Cullaro, MD

Last update posted

Aug 19, 2026

Last verified

Jul, 2026

Keywords

Acute Kidney Injury
Cirrhosis
Decompensated Cirrhosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Giuseppe Cullaro, MD on 2026-08-19.