Using droxidopa to improve kidney function in patients with liver cirrhosis and kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of droxidopa, an oral medication, in increasing blood pressure and improving kidney function in hospitalized patients with decompensated cirrhosis and acute kidney injury. Participants will be randomly assigned to receive either droxidopa or a placebo for 28 days, followed by a 30-day monitoring period. The study aims to determine if droxidopa can safely enhance mean arterial pressure, which is crucial for kidney recovery in these patients. By comparing the outcomes between the two groups, researchers hope to identify a new treatment option for a serious complication of liver disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Giuseppe Cullaro, MD, MAS — Columbia University
• Study coordinator: Giuseppe Cullaro, MD, MAS
• Email: gc2576@cumc.columbia.edu
• Phone: 2123050914

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.