Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (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 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.

Study Overview

• Status: Recruiting
• Conditions: Regional Citrate Anticoagulation (RCA); Continuous Renal Replacement Therapy (CRRT); Acute Kidney Injury (AKI)
• Intervention / Treatment: Drug: Prismocitrate 18; Device: PrisMax System Version 3.x with calcium line accessory

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Global CORP Clinical Trials Disclosure; Phone Number: +1 2249484283; Email: Global.CORP.ClinicalTrialsDisclosure@vantive.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • Recruiting
      • University of Alabama at Birmingham/UAB
      • Principal Investigator: Eric Judd, MD
  • California
    • Los Angeles, California, United States, 90095
      • Withdrawn
      • University of California Los Angeles
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California (USC) / Keck Hospital
      • Contact: Gina Kucherepa; Email: Gina.kucherepa@med.usc.edu
      • Contact: Carolina Unizony; Email: carolina.unizony@med.usc.edu
      • Principal Investigator: Fadi Tohme, MD
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami
      • Principal Investigator: Juan Duque, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Principal Investigator: Michael J Connor Jr., MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • University of Michigan
      • Principal Investigator: Lenar Yessayan, MD
  • Ohio
    • Springfield, Ohio, United States, 45504
      • Recruiting
      • Bon Secours Mercy Health-Springfield Regional Medical Center
      • Contact: Katrina Reynolds; Phone Number: 937-523-5300; Email: KReynolds@mercy.com
      • Principal Investigator: Sanju Varghese, MD
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Not yet recruiting
      • Geisinger Medical Center
      • Contact: Natacha A Morris; Email: nmantunesmorris@geisinger.edu
      • Principal Investigator: Maria C Bermudez, MD
    • Hershey, Pennsylvania, United States, 17033
      • Withdrawn
      • Penn State Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15240
      • Active, not recruiting
      • VA Pittsburgh Healthcare System
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Medical University of South Carolina (MUSC)
      • Contact: Angela Francisco; Email: millare@musc.edu
      • Principal Investigator: Blaithin McMahon, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • Lt. Col. Luke Weathers, Jr. VA Medical Center
      • Contact: Lillie Johnson; Email: Lillie.johnson3@va.gov
      • Principal Investigator: Geeta Gyamlani, MD
  • Texas
    • Dallas, Texas, United States, 75203
      • Not yet recruiting
      • Methodist Dallas Medical Center
      • Contact: Sophie He; Email: SophieHe@mhd.com
      • Principal Investigator: Roberto Collazo-Maldonado, MD
    • McAllen, Texas, United States, 78503
      • Active, not recruiting
      • Gamma Medical Research, Inc / McAllen Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory; This is a single-arm study. Patients will receive regional citrate anticoagulation (RCA) with Prismocitrate 18 (investigational drug) during their CRRT treatment using the PrisMax System Version 3.x with calcium line accessory (investigational device).

Drug: Prismocitrate 18; Prismocitrate 18 solution (investigational drug) will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol/L of blood. The flow rate for the anticoagulation of the extracorporeal circuit will be titrated to achieve a post-filter concentration of iCa of 0.25 to 0.35 mmol/L.; Device: PrisMax System Version 3.x with calcium line accessory; The RCA software on PrisMax System Version 3.x with calcium line accessory (investigational device) will be enabled to carefully guide the health practitioner for citrate dosing and calcium compensation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration	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.	Day 1 up to Day 10
Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration	Defined as symptomatic patients (e.g., changes in mental status not explained by the interventions or underlying conditions or cardiac events secondary to a shortened QT interval), with symptoms deemed attributable to hypercalcemia and with a confirmed systemic ionized calcium > 1.4 mmol/L.	Day 1 up to Day 10
Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration	Defined as symptomatic patients (e.g., refractory acidosis), with symptoms deemed attributable to citrate accumulation and with a systemic total calcium to ionized calcium ratio > 2.5.	Day 1 up to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events related to study product and/or procedure	Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section	Day 1 up to Day 28
Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x	Percentage of complete RCA treatments according to protocol	Day 1 up to Day 10

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Calcium
• Other Study ID Numbers: BXU558476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of Clinical Trial Data: The Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If the Sponsor agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of the Sponsor prior to the release of any data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes