Recruiting
Phase 3

Prismocitrate 18

Sponsor:

Vantive Health LLC

Code:

NCT05399537

Conditions

Regional Citrate Anticoagulation (RCA)

Continuous Renal Replacement Therapy (CRRT)

Acute Kidney Injury (AKI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prismocitrate 18

PrisMax System Version 3.x with calcium line accessory

Study Details

Brief 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.

Conditions

Regional Citrate Anticoagulation (RCA)

Continuous Renal Replacement Therapy (CRRT)

Acute Kidney Injury (AKI)

Study ID

NCT05399537

Start date

Jul 12, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

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.

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.

Primary outcome measure

  • Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration [ Time Frame: Day 1 up to Day 10 ]
  • Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration [ Time Frame: Day 1 up to Day 10 ]
  • Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration [ Time Frame: Day 1 up to Day 10 ]

Central Contacts and Locations

Central contacts

Global CORP Clinical Trials Disclosure

+1 2249484283Global.CORP.ClinicalTrialsDisclosure@vantive.com

Locations

University of Alabama at Birmingham/UAB

Recruiting

Birmingham, Alabama, United States, 35294-0007

Principal Investigator:

Eric Judd, MD

University of Southern California (USC) / Keck Hospital

Recruiting

Los Angeles, California, United States, 90033

Contacts

Gina Kucherepa

Gina.kucherepa@med.usc.edu

Carolina Unizony

carolina.unizony@med.usc.edu

Principal Investigator:

Fadi Tohme, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Michael J Connor Jr., MD

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Angela Francisco

millare@musc.edu

Principal Investigator:

Blaithin McMahon, MD

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

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Lillie Johnson

Lillie.johnson3@va.gov

Principal Investigator:

Geeta Gyamlani, MD

More Information

Sponsor

Vantive Health LLC

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vantive Health LLC on 2026-07-27.