ELISIO™-HX Dialyzer for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of a new artificial kidney, the ELISIO™-HX dialyzer, for individuals with kidney failure. The main goals are to determine if it maintains stable protein levels and enhances the body's ability to remove certain waste products. Individuals who regularly undergo hemodialysis and have a stable treatment routine may qualify for this study. The results could inform future dialysis options. As an unphased trial, this study allows patients to contribute to innovative research that may enhance future kidney treatments.
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 study team or your doctor.
What prior data suggests that the ELISIO™-HX Dialyzer is safe for kidney failure patients?
A previous study found the ELISIO™-HX Dialyzer to be safe for patients. This device functions like an artificial kidney, cleaning waste from the blood for individuals with kidney failure. Research has shown it does not significantly alter albumin levels, which is beneficial. Albumin, a protein in the blood, helps maintain fluid balance in the bloodstream.
The ELISIO™-HX is recognized for its precise filtering ability, effectively removing waste while keeping important proteins like albumin at safe levels. This is crucial for individuals at higher risk, such as those who are malnourished or frail.
Overall, early findings suggest the ELISIO™-HX is well-tolerated, with no major safety concerns reported.12345Why are researchers excited about this trial?
The ELISIO™-HX Dialyzer is unique because it introduces a novel medium cut-off technology designed to function as an artificial kidney for people with renal failure. Unlike traditional dialyzers, which may struggle to filter out larger toxins, the ELISIO™-HX aims to remove a broader range of molecules, potentially leading to better overall purification of the blood. Researchers are excited about this advancement because it could mean improved outcomes and quality of life for patients undergoing dialysis, offering a more comprehensive filtration process than current options.
What evidence suggests that the ELISIO™-HX dialyzer is effective for kidney failure?
Studies have shown that the ELISIO™-HX dialyzer, used by participants in this trial, effectively removes certain harmful substances from the blood in patients with kidney failure. Research indicates that this dialyzer efficiently removes specific medium-sized molecules called lambda free light chains, which can cause harm if they accumulate in the blood. One study found that both the ELISIO™-HX and a similar dialyzer effectively removed small and medium-sized molecules, with no major differences in performance. Additionally, the ELISIO™-HX is designed to protect important proteins like albumin, which are necessary for health, while still cleaning the blood effectively.12345
Who Is on the Research Team?
Kiranjit Dhillon, MD, MPH
Principal Investigator
Davita Norfolk Dialysis Center
Are You a Good Fit for This Trial?
This trial is for adults aged 22 and older with end-stage renal disease on hemodialysis, or those 18-21 weighing at least 40 kg. Participants must be clinically stable, have used the ELISIO-H dialyzer for 3 months prior to enrollment, expected to live at least another year, and able to consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment using the ELISIO™-HX dialyzer to evaluate safety and performance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ELISIO™-HX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nipro Medical Corporation
Lead Sponsor
Bright Research Partners
Industry Sponsor