Droxidopa for Liver Cirrhosis and Acute Kidney Injury

(DROP-AKI Trial)

Overseen By Giuseppe Cullaro, MD, MAS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Giuseppe Cullaro, MD

Must not be taking: MAOIs, Norepinephrine reuptake inhibitors

Disqualifiers: Severe cardiovascular disease, Age >70, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with droxidopa, such as MAOI inhibitors, norepinephrine reuptake inhibitors, and other investigational drugs.

Who Is on the Research Team?

Giuseppe Cullaro, MD, MAS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with liver cirrhosis who have developed acute kidney injury. Participants should not be in intensive care or require invasive treatments and must be able to take oral medication.

Inclusion Criteria

Ability to provide informed consent by subject or legally authorized representative

Consent to blood and urine collection for biomarker analysis

My liver condition is severe, as shown by tests or doctor's evaluation.

Exclusion Criteria

Any episode of a SBP ≥ 180 mmHg or a DBP ≥ 120 mmHg on two measurements, 1 minute apart

My kidney function is severely impaired.

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either droxidopa or placebo for 28 days to assess changes in mean arterial pressure and kidney function

28 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Droxidopa

Trial Overview The study tests if droxidopa, an oral medication, can improve blood pressure and aid kidney recovery in cirrhotic patients with kidney injury. It compares droxidopa's effectiveness against a placebo over a period of 28 days, followed by monitoring for another 30 days.

How Is the Trial Designed?

Group I: Droxidopa Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Giuseppe Cullaro, MD

Lead Sponsor