Droxidopa for Liver Cirrhosis and Acute Kidney Injury
(DROP-AKI Trial)
Trial Summary
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.
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.
Research Team
Giuseppe Cullaro, MD, MAS
Principal Investigator
Columbia University
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either droxidopa or placebo for 28 days to assess changes in mean arterial pressure and kidney function
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Droxidopa
Find a Clinic Near You
Who Is Running the Clinical Trial?
Giuseppe Cullaro, MD
Lead Sponsor