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New treatment option for Acute Kidney Injury
Official title Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury
ClinicalTrials.gov ID: NCT06937307
What this study is testing
What is Droxidopa capsules?
Droxidopa capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute kidney injury.
Also referred to as L-threo-3,4-dihydroxyphenylserine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.