Hemodialysis System for Kidney Disease

N/A

Waitlist Available

Research Sponsored by Diality Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to consent

Be older than 18 years old

Must not have

Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period

Awards & highlights

No Placebo-Only Group

Summary

This trial involves using a device that has been approved by the FDA for use in dialysis treatment. Patients who agree to participate will receive their regular dialysis treatment in a professional healthcare setting.

Who is the study for?

This trial is for patients with various stages of kidney disease, including those experiencing chronic kidney failure. Participants must be currently receiving in-center hemodialysis treatments and are willing to complete their usual dialysis using the Moda-Flx Hemodialysis System under professional supervision.

What is being tested?

The study is evaluating the performance of the Moda-Flx Hemodialysis System™ in a real-world clinical setting. Patients will undergo their regular dialysis sessions using this FDA-cleared device to assess its safety and effectiveness during standard treatment.

What are the potential side effects?

Since the trial involves a device already cleared by the FDA and not a new medication, side effects may relate more to typical risks associated with standard hemodialysis procedures rather than specific issues caused by the Moda-Flx system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have end-stage kidney disease and am on stable dialysis treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to understand and follow my dialysis treatment plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period

This trial's timeline: 3 weeks for screening, Varies for treatment, and samples will be collected before and after each dialysis treatment at visit 1, visit 2, visit 3 and at visit 4 over a two week period for reporting.