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New citrate solution aims to make kidney dialysis safer for Bleeding-Risk patients

NCT ID NCT05399537

Disease control Sponsor: Vantive Health LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 28, 2026 · Updated 5 times

Summary

This phase 3 trial is testing Prismocitrate 18, a special fluid used during continuous kidney dialysis to prevent blood clots in the dialysis machine. The study will enroll 40 adults with acute kidney injury who need dialysis and cannot use standard blood thinners. Researchers will monitor for dangerous calcium imbalances and citrate buildup over up to 10 days of treatment.

What this could mean

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

Active substance
Prismocitrate 18 (a citrate-based solution used to prevent blood clotting during kidney dialysis)
What this could lead to
If successful, this could confirm a safer way to prevent blood clots during continuous kidney dialysis, reducing bleeding risks for patients who cannot use standard blood thinners.
What could go wrong
This is a small, early-phase safety study with only 40 participants, so results may not apply to all patients. There are known risks of calcium imbalances (too low or too high) and citrate buildup, which could cause serious symptoms.

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

About 40 people

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

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Patients must be ≥18 years of age * Patients who are candidates for CRRT * Patients expected to survive for at least 24 hours * Patients with a contraindication to heparin or an increased risk of hemorrhage * Patient and/or legally-authorized representative has signed a written informed consent form (ICF) per 21 CFR Part 50.55(e) Exclusion Criteria: * Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity * Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease * Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \>10 * Patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/L) * Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation) * Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study Screening must have a negative serum beta human chorionic gonadotropic \[B-hCG\] pregnancy test at Screening) * Patients who are currently participating in another interventional clinical study

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

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

Acute kidney injury (AKI) Continuous renal replacement therapy (CRRT) Regional citrate anticoagulation (RCA)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Bon Secours Mercy Health-Springfield Regional Medical Center

    ACTIVE_NOT_RECRUITING

    Springfield, Ohio, 45504, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Gamma Medical Research, Inc / McAllen Medical Center

    ACTIVE_NOT_RECRUITING

    McAllen, Texas, 78503, United States

  • Geisinger Medical Center

    WITHDRAWN

    Danville, Pennsylvania, 17822, United States

  • Lt. Col. Luke Weathers, Jr. VA Medical Center

    RECRUITING

    Memphis, Tennessee, 38104, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Methodist Dallas Medical Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75203, United States

    Contact Email: •••••@•••••

  • Penn State Hershey Medical Center

    WITHDRAWN

    Hershey, Pennsylvania, 17033, United States

  • University of Alabama at Birmingham/UAB

    RECRUITING

    Birmingham, Alabama, 35294-0007, United States

  • University of California Los Angeles

    WITHDRAWN

    Los Angeles, California, 90095, United States

  • University of Miami

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Southern California (USC) / Keck Hospital

    RECRUITING

    Los Angeles, California, 90033, United States

  • VA Pittsburgh Healthcare System

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15240, United States

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