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NCT05399537 · ClinicalTrials.gov registry record · Phase 3

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

A Phase 3 study of Acute Kidney Injury (AKI) and Regional Citrate Anticoagulation (RCA), sponsored by Vantive Health.

Recruiting
Registry status
Phase 3
Development phase
40
Enrollment target
14
Study locations

NCT05399537: Recruiting Phase 3 study of Acute Kidney Injury (AKI) and Regional Citrate Anticoagulation (RCA), sponsored by Vantive Health.

NCT05399537 is a Phase 3 study of Acute Kidney Injury (AKI) and Regional Citrate Anticoagulation (RCA) that is actively recruiting participants, run by Vantive Health. The registered enrollment target is 40 participants, below the 4,628-participant average among 4 other Acute Kidney Injury (AKI) trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05399537, a Phase 3 study of Acute Kidney Injury (AKI) and Regional Citrate Anticoagulation (RCA), is actively recruiting participants, sponsored by Vantive Health.

RECRUITING
Registry status
Phase 3
Development phase
40 participants
Enrollment target
14
Study locations

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.

Primary Outcome

Defined as symptomatic patients (e.g., tetany/spasms, seizures, or cardiac events secondary to a prolonged QT interval), with symptoms deemed attributable to hypocalcemia and with a confirmed systemic ionized calcium \< 0.9 mmol/L.

Conditions Studied

Acute Kidney Injury (AKI) Regional Citrate Anticoagulation (RCA) Continuous Renal Replacement Therapy (CRRT)

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
Vantive Health

15 total trials

What NCT05399537 shows while recruiting

NCT05399537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 4,628-participant average among 4 other Acute Kidney Injury (AKI) trials with a reported enrollment target (99% lower).

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.

NCT05399537 lists 14 locations in 10 states (Pennsylvania, California, Texas).

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).

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).

Who is sponsoring clinical trial NCT05399537?

This trial is sponsored by Vantive Health, which has 15 total clinical trials registered on ClinicalTrials.gov.

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.

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More recruiting context for NCT05399537

Source: ClinicalTrials.gov NCT05399537, the US trial registry maintained by the National Library of Medicine. NCT05399537 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.