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Can a Citrate-Based blood thinner make continuous kidney dialysis safer?

NCT ID NCT05339139

Disease control Sponsor: Fresenius Medical Care North America Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Critically ill adults with acute kidney injury or end-stage kidney disease often need continuous renal replacement therapy, a slow form of dialysis that runs for hours or days. Blood tends to clot in the dialysis circuit, so doctors add a blood thinner. This study tests whether regional citrate anticoagulation, delivered by the multiFiltratePRO system, is safe for these patients. Researchers will track signs of calcium imbalance, acid-base problems, sodium levels, bleeding, and how long each dialysis circuit lasts.

What this could mean

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

Active substance
regional citrate anticoagulation delivered by the multiFiltratePRO system during continuous renal replacement therapy
What this could lead to
If it works, this could give doctors a safer way to keep dialysis circuits running for critically ill patients with kidney failure, with fewer bleeding problems than standard blood thinners.
What could go wrong
The study is small, with only 32 participants, so rare side effects may not show up. Citrate can build up in people whose livers cannot process it quickly, which can cause dangerous calcium imbalances.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

32 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: 1. Signed informed consent form by * The subject or * A legally authorized representative (LAR), if the subject is unable to consent 2. Adult patients ≥ 18 years old 3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT 4. Vascular access - Dialysis Catheter with size and location per institutional practice Exclusion Criteria: 1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55 2. A female who is pregnant or breast feeding 3. Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal 4. Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent 5. Previous participation in a similar or the same study. 6. Subjects already on continuous renal replacement therapy 7. Subjects with active COVID-19 infection 8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

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Conditions

The condition(s) this trial relates to.

acute kidney injury chronic kidney disease end stage renal failure

As listed by the trial registrant

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

Acute kidney injury ESRD

Contacts and locations

Locations

  • Advent Health Orlando

    Orlando, Florida, 32803, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Intermountain Health

    Murray, Utah, 84107, United States

  • John L. McClellan Memorial Veterans' Hospital

    Little Rock, Arkansas, 72205, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • University of Arkansas for Medical Sciences (UAMS)

    Little Rock, Arkansas, 72205, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109-5000, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39350, United States

  • Washington University - Hospital

    St Louis, Missouri, 63110, United States

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