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

ConditionsAcute Kidney InjuryCirrhosisDecompensated Cirrhosis of Liver
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGiuseppe Cullaro, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Serum creatinine >4.0 mg/dL or current renal replacement therapy

Age >70 years

Unstable angina

Congestive heart failure requiring escalating medical therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Droxidopa capsules

    Drug

    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

    Other intervention

    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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: DroxidopaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in mean arterial pressure (MAP)

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.

Time frame
Baseline to 28 days

Secondary outcomes

1

Change in serum creatinine

The difference in serum creatinine 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.

Time frame
28 days
2

All-cause mortality

The proportion of participants who die from any cause during the study period.

Time frame
58 days
3

Liver transplantation

The proportion of participants who undergo liver transplantation during the study period.

Time frame
58 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Giuseppe Cullaro, MD

Lead sponsor

Columbia University

Sponsor institution

Source ClinicalTrials.gov
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