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

Launched by GIUSEPPE CULLARO, MD · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called droxidopa to see if it can improve blood flow to the kidneys in patients with liver cirrhosis who experience kidney problems while in the hospital. When someone with cirrhosis has kidney injury, improving their blood pressure can help their kidneys recover. The trial will compare droxidopa to a placebo (an inactive pill) in 75 hospitalized patients with cirrhosis and kidney injury. Participants will take the medication or placebo for 28 days, and their blood pressure and kidney function will be monitored for an additional 30 days. This research could lead to a new treatment option for patients facing a serious complication of liver disease.

To be eligible for this trial, participants must be at least 18 years old, hospitalized at Columbia University Irving Medical Center, and have specific health conditions related to cirrhosis and kidney injury. They should be able to take oral medications and provide consent for blood and urine tests. However, individuals with severe kidney problems, certain heart conditions, or those who are pregnant or breastfeeding cannot participate. If someone qualifies and joins the study, they will receive care and monitoring throughout the trial to assess the effectiveness and safety of droxidopa for improving their health.

Gender

ALL

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