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Prismocitrate 18 · 1 trial · 3 indications
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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). |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * 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 writte...
Prismocitrate 18 is an investigational small molecule being developed for Regional Citrate Anticoagulation (RCA), a method used to prevent blood clotting during Continuous Renal Replacement Therapy (CRRT) in patients with Acute Kidney Injury (AKI). It is currently in Phase 3 clinical development.
Prismocitrate 18 is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The drug is currently in Phase 3 clinical development for Regional Citrate Anticoagulation.
Prismocitrate 18 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied for use in Regional Citrate Anticoagulation during Continuous Renal Replacement Therapy.
Prismocitrate 18 is being evaluated in a Phase 3 clinical trial with the identifier NCT05399537. This trial is titled 'Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT' and is currently recruiting participants in the United States.
Prismocitrate 18 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. It is being studied for Regional Citrate Anticoagulation in patients receiving Continuous Renal Replacement Therapy, but it has not yet received regulatory approval.