QUELIMMUNE for Acute Kidney Injury
(SAVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety of a treatment called QUELIMMUNE for children and young adults with severe kidney issues caused by infections like sepsis. The goal is to determine if those treated with QUELIMMUNE experience fewer new bloodstream infections in the first month compared to those who do not receive this treatment. Eligible patients should already be receiving QUELIMMUNE for kidney problems related to sepsis. As a Phase 2 trial, this research measures how well QUELIMMUNE works in an initial, smaller group, providing an opportunity to contribute to important medical advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the QUELIMMUNE device?
Research has shown that QUELIMMUNE is safe for children with sudden kidney problems caused by sepsis. Studies have found no harmful side effects directly linked to the device. The FDA approved QUELIMMUNE under a special category called Humanitarian Device Exemption (HDE), indicating it is safe and likely beneficial for these patients. However, like any medical device, a small risk of infection exists if it is not kept clean. Overall, evidence suggests that QUELIMMUNE is well-tolerated.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about the QUELIMMUNE device because it offers a new approach to managing pediatric immune-related conditions, potentially providing a more personalized and precise treatment option. Unlike standard treatments, which often involve broad-acting medications, QUELIMMUNE is designed to work specifically under the Humanitarian Device Exemption (HDE) indication, suggesting a targeted and patient-specific intervention. This specificity could lead to fewer side effects and a more effective management of the condition, making it a promising alternative to current therapies.
What evidence suggests that the QUELIMMUNE device is effective for treating AKI due to sepsis?
Research has shown that the QUELIMMUNE device could help treat children with sudden kidney problems caused by sepsis. Studies found that 75% of patients using the device survived for at least 28 days, surpassing many past survival rates for this serious condition. No safety issues directly linked to the device have been reported so far. Although the FDA has approved the device for this use, its full effectiveness is still under study and comparison with other treatments. Participants in this trial will join the QUELIMMUNE Surveillance Registry to monitor outcomes and gather further data on its use in clinical practice.12567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the QUELIMMUNE device under the HDE for AKI due to sepsis
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on new bloodstream infections
What Are the Treatments Tested in This Trial?
Interventions
- QUELIMMUNE (SCD-PED)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SeaStar Medical
Lead Sponsor
Citations
1.
investors.seastarmedical.com
investors.seastarmedical.com/news-releases/news-release-details/seastar-medical-reports-positive-early-results-quelimmuneRelease Details
In addition, outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to ...
2.
renalinterventions.net
renalinterventions.net/first-data-from-save-registry-on-track-to-validate-use-of-quelimmune-in-treatment-of-paediatric-aki/First data from SAVE registry on track to validate use of ...
Specific outcomes data will include 90-day survival and dialysis dependency along with safety data with plans to compare to an existing control ...
3.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/quelimmune-shows-promise-in-pediatric-acute-kidney-injury/Quelimmune Shows Promise in Pediatric Acute Kidney Injury
The data from the first 20 patients showed no device-related safety issues and a 75% survival rate at 28 days, potentially exceeding the ...
SeaStar Medical Reports Positive Results for ...
These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney ...
QUELIMMUNE
The effectiveness of this device for this use has not been demonstrated. The Selective Cytopheretic Device for Pediatrics (SCD-PED) is ...
Study Details | NCT06517810 | QUELIMMUNE (SCD-PED) ...
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition ...
QUELimmune
QUELIMMUNE was granted approval under a Humanitarian Device Exemption (HDE) by FDA in February 2024 with clinical data establishing safety and probable benefit ...
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