Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
1 other identifier
interventional
40
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2024
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
July 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 13, 2026
April 1, 2026
2.4 years
May 27, 2022
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Number of participants with Adverse Events related to study product and/or procedure
Day 1 up to Day 28
Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x
Day 1 up to Day 10
Study Arms (1)
Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory
EXPERIMENTALThis 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 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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantive Health LLClead
- Baxter Healthcare Corporationcollaborator
Study Sites (14)
University of Alabama at Birmingham/UAB
Birmingham, Alabama, 35294-0007, United States
University of Southern California (USC) / Keck Hospital
Los Angeles, California, 90033, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, 38104, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas, 78503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Global CORP Clinical Trials Disclosure
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
July 12, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Upon approval of a legitimate research request.
- 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
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)