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Kidney disease

Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

Recruiting · 5 sites across 5 states

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Be between 18 and 80 years old (and your care partner must be at least 18).
  • Have end-stage kidney disease (ESKD) that is being treated with regular maintenance dialysis.
  • Have stable, working blood access for dialysis (a tunneled central venous catheter, arteriovenous fistula, or graft) that can support blood flow of at least 300 ml/min.
  • Be considered stable by your kidney specialist before the end of the screening period.
  • Be able to complete a Skills and Comprehension Assessment with a care partner before training ends.

🚫 You may not be able to join if…

  • Have hemoglobin (Hgb) less than 9 g/dL at screening.
  • Have symptoms of low blood pressure during dialysis that needed medical treatment in at least two treatments during the run-in period.
  • Have a documented history of not following dialysis therapy in a way that would prevent completing the study.
  • Have an average ultrafiltration rate greater than 13 mL/kg/hour in the last 2 weeks before screening (from medical records).
  • Have had a significant cardiovascular (heart/vessel) adverse event within the last 90 days before screening.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 18–80
  • !Some conditions may not be a fit: Heart / cardiovascular disease

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT06613568 · Locations: California · New York · Tennessee · Texas · Washington