Prismocitrate 18 for Acute Kidney Injury

Recruiting at 11 trial locations

Overseen By Global CORP Clinical Trials Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vantive Health LLC

Disqualifiers: Citrate allergy, Liver failure, Refractory shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with a contraindication to heparin or an increased risk of hemorrhage are included, which might imply some medications could be continued. It's best to discuss your specific medications with the trial team.

What makes the drug Prismocitrate 18 unique for treating acute kidney injury?

Prismocitrate 18 is unique because it is used as an anticoagulant in continuous renal replacement therapy (CRRT), which helps manage blood clotting during the treatment of acute kidney injury. This is different from other treatments that primarily focus on fluid management or pharmacological interventions without addressing clotting issues directly. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

Adults (18+) needing continuous renal replacement therapy (CRRT) for acute kidney injury, who can't use heparin due to bleeding risks or other contraindications. They must be expected to live at least 24 hours and give written consent.

Inclusion Criteria

Patients expected to survive for at least 24 hours

I am a candidate for continuous renal replacement therapy.

I cannot take heparin or have a high risk of bleeding.

Exclusion Criteria

Patients who are currently participating in another interventional clinical study

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

I have severe shock and high lactate levels in my blood.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive CRRT with Prismocitrate 18 using the PrisMax System for up to 10 days

10 days

Continuous monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Regular check-ins to monitor adverse events

Treatment Details

Interventions

• Prismocitrate 18

Trial Overview Prismocitrate 18 is being tested as a CRRT solution that also prevents blood clots during treatment. The study will see if it's safe when used with specific CRRT methods over up to 10 days.

Participant Groups

Group I: Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory Experimental Treatment 2 Interventions

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).

Prismocitrate 18 is already approved in European Union, Canada, India for the following indications:

Approved in European Union as Prismocitrate 18 for:

• Prevention of blood clotting in extracorporeal circuits during CRRT

Approved in Canada as Prismocitrate 18 for:

• Prevention of blood clotting in extracorporeal circuits during CRRT

Approved in India as Prismocitrate 18 for:

• Prevention of blood clotting in extracorporeal circuits during CRRT

Who Is Running the Clinical Trial?

Vantive Health LLC

Lead Sponsor

Trials

49

Recruited

4,500+

Baxter Healthcare Corporation

Industry Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Findings from Research

In a study of 100 critically ill patients with acute kidney injury (AKI), a restrictive fluid management strategy led to a significantly lower cumulative fluid balance at 72 hours compared to usual care, with a mean difference of -1148 mL.

Patients in the restrictive fluid management group required renal replacement therapy less frequently (13%) than those in the usual care group (30%), suggesting that this approach may reduce the need for more invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restrictive fluid management versus usual care in acute kidney injury (REVERSE-AKI): a pilot randomized controlled feasibility trial. Vaara, ST., Ostermann, M., Bitker, L., et al.[2021]

Acute renal failure (ARF) is a serious condition in critically ill patients, where even slight decreases in kidney function can significantly increase morbidity and mortality; early detection using new biomarkers like NGAL and KIM-1 can help prevent severe damage before traditional indicators like serum creatinine levels rise.

Preventive strategies, such as maintaining hydration and avoiding nephrotoxins, are crucial, and while many potential pharmacological treatments are being explored, effective evidence-based options are still needed to improve outcomes in ARF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel aspects of pharmacological therapies for acute renal failure. Kunzendorf, U., Haase, M., Rölver, L., et al.[2022]

The study proposes a new way to define Acute Kidney Injury (AKI) by linking functional changes (like serum creatinine levels) and structural biomarkers (like urinary neutrophil-gelatinase-associated-lipocalin) based on their sensitivity to outcomes such as death and the need for dialysis.

In a cohort of critically ill patients, specific thresholds for these biomarkers were identified, showing that patients with combined structural and functional AKI had a significantly higher risk of death or dialysis (3.11 times higher) compared to those without AKI, indicating the importance of these biomarkers in assessing kidney injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking injury to outcome in acute kidney injury: a matter of sensitivity. Pickering, JW., Endre, ZH.[2021]

In a study of 330 burn patients, those who received restrictive fluid resuscitation (less than the standard volume) had a significantly higher risk of developing acute kidney injury (AKI), with an odds ratio of 3.25, indicating more than three times the likelihood compared to those receiving standard volumes.

Despite the increased risk of AKI with restrictive resuscitation, there were no significant differences in rates of burn wound infections or pneumonia among the different fluid resuscitation groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. Mason, SA., Nathens, AB., Finnerty, CC., et al.[2018]

Current reliance on serum creatinine to monitor acute kidney injury (AKI) is inadequate due to its delayed response, highlighting the urgent need for early biomarkers for timely diagnosis and treatment.

Five promising urinary biomarkers for AKI—kidney injury molecule-1, N-acetyl-Beta-D-glucosaminidase, neutrophil gelatinase-associated lipocalin, cystatin C, and interleukin-18—are being validated, which could lead to improved early diagnosis and treatment options for patients with AKI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of acute kidney injury: from classic parameters to new biomarkers. Bonventre, JV.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Restrictive fluid management versus usual care in acute kidney injury (REVERSE-AKI): a pilot randomized controlled feasibility trial. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Novel aspects of pharmacological therapies for acute renal failure. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Linking injury to outcome in acute kidney injury: a matter of sensitivity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnosis of acute kidney injury: from classic parameters to new biomarkers. [2022]