Status:
RECRUITING
Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
Lead Sponsor:
Giuseppe Cullaro, MD
Conditions:
Acute Kidney Injury
Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ci...
Detailed Description
Acute kidney injury (AKI) occurs in up to 50% of hospitalized patients with decompensated cirrhosis and carries mortality rates exceeding 50%. Recent evidence indicates that progression of AKI after i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06937307
Start Date
May 27 2025
End Date
December 31 2027
Last Update
June 4 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032