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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
14 sites in 1 country
United States14 sites, 8 recruiting
- 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
- Withdrawn
Geisinger Medical Center
Danville, Pennsylvania, 17822
- Withdrawn
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
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
- Withdrawn
University of California Los Angeles
Los Angeles, California, 90095
- Terminated
Gamma Medical Research, Inc / McAllen Medical Center
McAllen, Texas, 78503
- Recruiting
Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee, 38104
Lillie Johnson, Lillie.johnson3@va.gov
Geeta Gyamlani, MD
- Not yet recruiting
University of Miami
Miami, Florida, 33136
Juan Duque, MD
- Terminated
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
- Terminated
Bon Secours Mercy Health-Springfield Regional Medical Center
Springfield, Ohio, 45504
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
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)
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT)
- ClinicalTrials.gov ID
- NCT05399537
- Acronym / sponsor ID
- BXU558476
- Conditions
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory | Experimental | Drug: Prismocitrate 18, Device: PrisMax System Version 3.x with calcium line accessoryThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prismocitrate 18Prismocitrate 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. | Drug | Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory |
| PrisMax System Version 3.x with calcium line accessoryThe 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. | Device | Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory |
Primary outcome
Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration
Time frame: Day 1 up to Day 10
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.
Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration
Time frame: Day 1 up to Day 10
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.
Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration
Time frame: Day 1 up to Day 10
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.
2 secondary outcomes
Number of participants with Adverse Events related to study product and/or procedure
Time frame: Day 1 up to Day 28
Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x
Time frame: Day 1 up to Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: 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)
Related trials for Regional Citrate Anticoagulation (RCA)
Not yet recruitingObservational study
Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation
Acute Kidney Injury, Renal Failure
Not yet recruiting
Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment
AKI - Acute Kidney Injury, CKD 5D, Hemodialysis
Recruiting
Comparison of RCA and RACD in Extra-renal Purification by SLED
Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Global CORP Clinical Trials Disclosure contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Global CORP Clinical Trials Disclosure (+1 2249484283, Global.CORP.ClinicalTrialsDisclosure@vantive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration (time frame: Day 1 up to Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.