Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT

Launched by VANTIVE HEALTH LLC · May 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a new solution called Prismocitrate 18, which is used during a specific type of treatment known as Continuous Renal Replacement Therapy (CRRT). This treatment is often necessary for patients with Acute Kidney Injury (AKI) who need assistance with their kidney function. The trial aims to ensure that Prismocitrate 18 is safe for patients receiving CRRT and that it can effectively prevent blood clots during this treatment. Participation in the study may last up to 10 days.

To qualify for the trial, participants must be at least 18 years old and be candidates for CRRT. They should also be expected to survive for at least 24 hours and must not be able to take heparin, a common blood thinner. However, individuals with certain conditions, like severe liver problems or allergies to citrate, will not be eligible. Participants will be required to sign a consent form to join the study, and both men and women can take part, although pregnant or breastfeeding women are excluded. This trial is currently recruiting participants, and it provides an opportunity to help advance treatment options for patients with kidney issues.

Gender

ALL

Eligibility criteria

• 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 written informed consent form (ICF) per 21 CFR Part 50.55(e)
• Exclusion Criteria:
• • 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