Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vantive Health LLC
Study ID
NCT05399537
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Kidney Injury (AKI)
  • Continuous Renal Replacement Therapy (CRRT)
  • Regional Citrate Anticoagulation (RCA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prismocitrate 18 — DRUG
    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 — DEVICE
    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 Details

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.

Key Dates

Start date
Jul 12, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham/UABBirminghamAlabama35294-0007
Eric Judd, MD (PRINCIPAL_INVESTIGATOR)
University of California Los AngelesLos AngelesCalifornia90095-
University of Southern California (USC) / Keck HospitalLos AngelesCalifornia90033
Gina Kucherepa
[email protected]
Carolina Unizony
[email protected]
Fadi Tohme, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Juan Duque, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Michael J Connor Jr., MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Lenar Yessayan, MD (PRINCIPAL_INVESTIGATOR)
Bon Secours Mercy Health-Springfield Regional Medical CenterSpringfieldOhio45504
Katrina Reynolds
[email protected]
937-523-5300
Sanju Varghese, MD (PRINCIPAL_INVESTIGATOR)
Geisinger Medical CenterDanvillePennsylvania17822
Natacha A Morris
[email protected]
Maria C Bermudez, MD (PRINCIPAL_INVESTIGATOR)
Penn State Hershey Medical CenterHersheyPennsylvania17033-
VA Pittsburgh Healthcare SystemPittsburghPennsylvania15240-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425
Angela Francisco
[email protected]
Blaithin McMahon, MD (PRINCIPAL_INVESTIGATOR)
Lt. Col. Luke Weathers, Jr. VA Medical CenterMemphisTennessee38104
Lillie Johnson
[email protected]
Geeta Gyamlani, MD (PRINCIPAL_INVESTIGATOR)
Methodist Dallas Medical CenterDallasTexas75203
Roberto Collazo-Maldonado, MD (PRINCIPAL_INVESTIGATOR)
Gamma Medical Research, Inc / McAllen Medical CenterMcAllenTexas78503-

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University of Alabama at Birmingham/UAB· Birmingham, ALUniversity of California Los Angeles· Los Angeles, CAUniversity of Southern California (USC) / Keck Hospital· Los Angeles, CAUniversity of Miami· Miami, FLEmory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MI

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