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Can a blood pressure pill rescue failing kidneys in cirrhosis?

NCT ID NCT06937307

Disease control Sponsor: Giuseppe Cullaro, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether droxidopa, an oral medication that raises blood pressure, can improve kidney function in people hospitalized with cirrhosis and acute kidney injury. The study will compare droxidopa to a placebo in 75 participants, measuring changes in blood pressure and kidney function over 28 days of treatment plus 30 days of follow-up. The goal is to see if this simple pill could help kidneys recover without invasive procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Droxidopa, an oral medication that raises blood pressure by converting to norepinephrine in the body
What this could lead to
If effective, droxidopa could offer a simple oral treatment to support kidney recovery in hospitalized cirrhosis patients with acute kidney injury, potentially reducing the need for intensive care.
What could go wrong
This is an early-phase trial with a modest size, so results may not be conclusive. The drug may not improve kidney function, and it could cause side effects like high blood pressure or heart rhythm issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute kidney injury chronic liver failure cirrhosis of liver Fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Cirrhosis Decompensated cirrhosis of liver

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

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