Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidne… (NCT06937307) | Clinical Trial Compass
RecruitingPhase 2
Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
United States75 participantsStarted 2025-05-27
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.