Prismocitrate 18 for Acute Kidney Injury

Recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Prismocitrate 18 for individuals with acute kidney injury requiring continuous renal replacement therapy (CRRT). The researchers aim to determine if Prismocitrate 18 safely and effectively prevents blood clots during CRRT using a specialized machine system. The trial seeks patients who need CRRT but cannot use heparin, a common blood thinner, due to bleeding risks. Participants will use the treatment for up to 10 days. As a Phase 3 trial, this represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Prismocitrate 18 is likely to be safe for humans?

Research has shown that citrate-based blood thinners, such as Prismocitrate 18, are generally safe for individuals with sudden kidney problems requiring continuous kidney support. Some studies have found that citrate solutions might be safer than heparin, another blood thinner, as they can cause fewer bleeding issues. Users of citrate solutions like Prismocitrate 18 have experienced fewer blood clots in the treatment machine, enhancing safety. Although there have been reports of minor side effects, such as changes in calcium levels, doctors can usually manage these easily. As this study is in a late phase, strong evidence already indicates that the treatment is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Prismocitrate 18 is unique because it introduces a new approach to managing acute kidney injury with regional citrate anticoagulation (RCA). Unlike traditional anticoagulants used during continuous renal replacement therapy (CRRT), like heparin, which can pose bleeding risks, Prismocitrate 18 provides a localized anticoagulant effect, potentially reducing systemic bleeding complications. Additionally, it's used with the PrisMax System's advanced technology, which streamlines the process and enhances safety with its calcium line accessory. Researchers are excited about Prismocitrate 18 because it could offer a safer, more efficient way to support kidney function in critically ill patients.

What evidence suggests that Prismocitrate 18 is effective for acute kidney injury?

Research shows that Prismocitrate 18 works effectively as a blood thinner for patients undergoing continuous kidney treatment (CRRT) for acute kidney issues. Studies have found that citrate-based blood thinners like Prismocitrate 18 can be safer and more effective than traditional options like heparin, particularly in preventing clots in the blood circuit outside the body during treatment. Specifically, patients using Prismocitrate 18 experienced longer-lasting treatment circuits, demonstrating its effectiveness. Additionally, this treatment has shown safety with few side effects. Overall, evidence supports Prismocitrate 18 as a promising option for managing blood clotting during CRRT. Participants in this trial will receive regional citrate anticoagulation with Prismocitrate 18 during their CRRT treatment using the PrisMax System Version 3.x with a calcium line accessory. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02860130

Clinical Evaluation of Use of Prismocitrate 18 in Patients ... The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4364313/

Efficacy and safety of citrate-based anticoagulation ... Efficacy and safety of citrate-based anticoagulation compared to heparin in patients with acute kidney injury requiring continuous renal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2529984025000424

Incidence of adverse events in patients undergoing ... Patients with AKI treated with renal replacement therapy and sodium citrate (Prismocitrate 18/0 mmol/L [0.5%]) were included. Patients with liver failure, ...

4. trial.medpath.com trial.medpath.com/clinical-trial/a5a3d73d3448cb22/nct05399537-safety-evaluation-prismocitrate-18-crrt

Safety Evaluation of Prismocitrate 18 in Patients Receiving ... Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent ...

5. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05399537

Prismocitrate 18 in Patients Receiving CRRT Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent ...

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT05399537

Prismocitrate 18 in Patients Receiving CRRT The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05399537

NCT05399537 | Safety Evaluation of Prismocitrate 18 in ... The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) ...

8. withpower.com withpower.com/trial/phase-3-continuous-renal-replacement-therapy-5-2022-b33e6

Prismocitrate 18 for Acute Kidney Injury The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) ...