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RECRUITING Phase 3

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

NCT05399537 · View on ClinicalTrials.gov ↗

Study Summary

Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate anticoagulation (RCA) software to facilitate citrate and calcium compensation prescription. The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH) and 2) to observe that the software and interface for the PrisMax System Version 3.x with calcium line accessory allows for implementation of regional citrate anticoagulation (RCA) (citrate and calcium dosing) during CRRT with Prismocitrate 18 and intended prescription. The study period of the patient's CRRT will be up to 10 days.

Interventions

  • DRUG Prismocitrate 18
  • DEVICE PrisMax System Version 3.x with calcium line accessory

Study Locations (14)

Pennsylvania

  • Geisinger Medical Center — Danville
  • Penn State Hershey Medical Center — Hershey
  • VA Pittsburgh Healthcare System — Pittsburgh

California

  • University of Southern California (USC) / Keck Hospital — Los Angeles
  • University of California Los Angeles — Los Angeles

Texas

  • Methodist Dallas Medical Center — Dallas
  • Gamma Medical Research, Inc / McAllen Medical Center — McAllen

Alabama

  • University of Alabama at Birmingham/UAB — Birmingham

Florida

  • University of Miami — Miami

Georgia

  • Emory University — Atlanta

Michigan

  • University of Michigan — Ann Arbor

Ohio

  • Bon Secours Mercy Health-Springfield Regional Medical Center — Springfield

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-07-12
Est. Completion 2026-12
Phase Phase 3

Sponsor

Vantive Health

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05399537

The ClinicalTrials.gov registry entry for NCT05399537 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vantive Health, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Acute Kidney Injury (AKI) appearing as the primary indexed condition, and to 2 interventions — of which Prismocitrate 18 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05399537 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Pennsylvania, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05399537 about?

NCT05399537 is a clinical study titled "Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT". Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate antico...

What is the current status of trial NCT05399537?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2024-07-12. Estimated completion is 2026-12.

What conditions does trial NCT05399537 study?

This clinical trial studies the following conditions: Acute Kidney Injury (AKI), Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05399537?

The interventions under investigation include: Prismocitrate 18 (DRUG), PrisMax System Version 3.x with calcium line accessory (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05399537?

This trial is sponsored by Vantive Health, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05399537 being conducted?

This trial has 14 study locations across Alabama, California, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial