Regional Citrate Anticoagulation (RCA)Phase 3NCT05399537

Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

A Phase 3 study testing Prismocitrate 18 and PrisMax System Version 3.x with calcium line accessory in people with Regional Citrate Anticoagulation (RCA) and Continuous Renal Replacement Therapy (CRRT), run by Vantive Health LLC at 14 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
What is being tested?: Prismocitrate 18 and PrisMax System Version 3.x with calcium line accessory
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 14 sitesUnited States
Study dates: 12 Jul 2024to Jan 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Global CORP Clinical Trials Disclosure contact

+1 2249484283

Global.CORP.ClinicalTrialsDisclosure@vantive.com

City, postcode or hospital

Sites recruiting now only

14 sites in 1 country

United States14 sites, 8 recruiting

University of Michigan
Ann Arbor, Michigan, 48109
Lenar Yessayan, MD
Recruiting
Emory University
Atlanta, Georgia, 30322
Michael J Connor Jr., MD
Recruiting
University of Alabama at Birmingham/UAB
Birmingham, Alabama, 35294-0007
Eric Judd, MD
Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Angela Francisco, millare@musc.edu
Blaithin McMahon, MD
Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Colette G Ngo Ndjom, M.S., ClinicalResearch@mhd.com
Ravina Linenfelser, MD
Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Withdrawn
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Withdrawn
University of Southern California (USC) / Keck Hospital
Los Angeles, California, 90033
Gina Kucherepa, Gina.kucherepa@med.usc.edu
Carolina Unizony, carolina.unizony@med.usc.edu
Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Withdrawn
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas, 78503
Terminated
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, 38104
Lillie Johnson, Lillie.johnson3@va.gov
Geeta Gyamlani, MD
Recruiting
University of Miami
Miami, Florida, 33136
Juan Duque, MD
Not yet recruiting
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
Terminated
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, 45504
Terminated

Other trials in United States

About this study

Official title: 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.

Conditions: Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
Being tested: Prismocitrate 18, PrisMax System Version 3.x with calcium line accessory
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prismocitrate 18Drug
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 accessoryDevice
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.

Study groups in NCT05399537
Study group	Role	What they receive
Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory	Experimental	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). Receives: Drug: Prismocitrate 18; Device: PrisMax System Version 3.x with calcium line accessory

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 10

Secondary outcomes (2)

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
Measured: 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
Measured: Day 1 up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 2024Jan 2027

First posted1 Jun 2022
Study start12 Jul 2024
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Regional Citrate Anticoagulation (RCA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05399537
Sponsor's protocol ID: BXU558476
Status last verified: Sep 2026
First submitted: 27 May 2022
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: 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)