NCT06937307 Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
| NCT ID | NCT06937307 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Giuseppe Cullaro, MD |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2025-05-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Giuseppe Cullaro, MD, MAS
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06937307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06937307 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06937307 currently recruiting?
Yes, NCT06937307 is actively recruiting participants. Contact the research team at gc2576@cumc.columbia.edu for enrollment information.
Where is the NCT06937307 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06937307 clinical trial?
NCT06937307 is sponsored by Giuseppe Cullaro, MD. The principal investigator is Giuseppe Cullaro, MD, MAS at Columbia University. The trial plans to enroll 75 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.