Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT
Recruiting · Phase 3 · NCT05399537
Conditions: Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury (AKI)
At a glance
- Research payments reported, 2025
- $241,646
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 40
About the trial
- Sponsor
- Vantive Health LLC (with Baxter Healthcare Corporation)
- Tested
- Prismocitrate 18 (drug), PrisMax System Version 3.x with calcium line accessory (device)
- Dates
- Started 2024-07-12; completion 2027-01
- Results posted
- Not yet
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 …
From ClinicalTrials.gov, last updated 2026-10-05. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Vantive US Healthcare LLC reported $241,646 in research payments for this study in 2025 (79 payments).
Products named: Renal - Prismocitrate
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Fadi Tohme, MD Nephrology (Kidney) · Los Angeles, CA
- Geeta G. Gyamlani, MD Critical Care Medicine · Jackson, MS
- Sanju A. Varghese, MD Nephrology (Kidney) · Springfield, OH
- Ronald P. Miller, MD Nephrology (Kidney) · Hershey, PA
- Mohan Ramkumar, MD Nephrology (Kidney) · Pittsburgh, PA
- Roberto Collazo-maldonado, M.D. Nephrology (Kidney) · Dallas, TX
- Sergio Alberto Trevino Manllo, MD Nephrology (Kidney) · Mcallen, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Research Incorporated $90,441
- University of Southern California $51,225
- Gamma Medical Research, Inc. $32,555
- Bon Secours Mercy Health Inc $26,900
- Methodist Dallas Medical Center, TX $25,324
- Pennsylvania State University $11,700
- Veterans Research Foundation of Pittsburgh $3,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.