Moda-flx Hemodialysis System for Kidney Failure

Recruiting at 3 trial locations

Overseen By Michael Gastauer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Diality Inc.

Disqualifiers: Anemia, Hypotension, Non-adherence, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dialysis method for individuals with end-stage kidney disease, using the Moda-flx Hemodialysis System™. The researchers aim to determine if this system is safe and effective in both professional care settings and at home with a partner's assistance. They seek participants with stable dialysis routines who can collaborate with a caregiver. This trial may suit those with kidney failure who regularly undergo dialysis with a stable blood flow setup. As an unphased trial, it offers a unique opportunity to contribute to innovative dialysis research that could enhance future treatment options.

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 prior data suggests that the Moda-flx Hemodialysis System™ is safe for use in professional care and at home?

Research has shown that the Moda-flx Hemodialysis System received FDA approval for use in professional healthcare settings, indicating it has passed safety checks for medical professionals. In earlier studies, participants underwent up to four dialysis treatments with this system over two weeks to assess both safety and effectiveness.

Although specific side effects from these studies are not detailed, FDA approval implies that major safety issues have been addressed. The system is designed for use in healthcare settings and at home by trained individuals. This flexibility suggests it is well-tolerated under professional supervision and may be safe for home use with proper training.

This trial will further evaluate the system's safety and effectiveness for home use, an important step to ensure it functions safely outside a hospital setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Moda-flx Hemodialysis System™ because it offers a new approach to dialysis treatments for kidney failure. Unlike traditional hemodialysis, which is typically done in a clinical setting, this system allows for flexibility by enabling treatment both in professional care and at home. This innovation could make dialysis more accessible and convenient for patients, potentially improving their quality of life by reducing the frequency of hospital visits. Additionally, the ability to receive treatment at home could lessen the burden on healthcare facilities and provide patients with more control over their treatment schedule.

What evidence suggests that the Moda-flx Hemodialysis System™ is effective for kidney failure?

Research shows that the Moda-flx Hemodialysis System™ is designed for people with end-stage kidney disease who are stable on regular dialysis. For these patients, the system effectively cleans the blood by meeting specific targets for dialysis adequacy, meaning it removes waste products well. In this trial, participants will receive dialysis therapy using the Moda-flx Hemodialysis System™ in both professional care settings and at home. Although the full effectiveness in everyday use is still under study, early results suggest it can successfully support ongoing dialysis needs. ^{1 4 6 7 8}

Who Is on the Research Team?

Cynthia Silva, MD

Principal Investigator

Diality Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with end-stage kidney disease (ESKD) who are stable on maintenance dialysis and have a well-functioning vascular access. Participants must be able to complete training with a Care Partner and pass a Skills Assessment as judged by the study investigator.

Inclusion Criteria

Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.

My vascular access for treatment works well and can handle 300 ml/min.

I am between 18 and 80 years old, and my care partner is at least 18.

Exclusion Criteria

Hgb level of < 9 g/dL at Screening

Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study

Participant had an average ultrafiltration rate > 13 mL/kg/hour during the last 2 weeks prior to Screening, per medical records

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Professional Care Treatment

Participants receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting

10 weeks

Weekly visits for dialysis

At Home Treatment

Participants receive dialysis therapy using the Moda-Flx Hemodialysis System™ at home

10 weeks

Weekly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moda-flx Hemodialysis System™

Trial Overview The Moda-flx Hemodialysis System™ is being tested for safety and effectiveness in both professional care settings by trained staff, and at home by participants themselves along with their Care Partners.

How Is the Trial Designed?

Group I: Professional Care and At Home Experimental Treatment 1 Intervention

Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting

Who Is Running the Clinical Trial?

Diality Inc.

Lead Sponsor

Trials

2

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06581393

First Evaluation of the Moda-Flx Hemodialysis System™ in ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06613568

Moda-flx Hemodialysis System™ Under Professional Care ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

3. withpower.com withpower.com/trial/phase-kidney-failure-chronic-9-2024-8e571

Moda-flx Hemodialysis System for Kidney Failure This trial is for individuals with end-stage kidney disease (ESKD) who are stable on maintenance dialysis and have a well-functioning vascular access.

4. ctv.veeva.com ctv.veeva.com/study/first-evaluation-of-the-moda-flx-hemodialysis-system-in-real-world-clinical-settings

First Evaluation of the Moda-Flx Hemodialysis System™ in ... 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 ≥ ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11706171/

Real-world effectiveness of hemodialysis modalities Results from the CONVINCE clinical trial suggest a 23% mortality risk reduction among patients receiving high-volume (> 23 L) hemodiafiltration.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233798.pdf

August 2, 2024 Diality, Inc. Amnon Talmor Director ... The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device, ...

7. diality.com diality.com/

Welcome to Diality The Moda-flx Hemodialysis System received U.S. Food and Drug Administration (FDA) clearance for use in professional care settings in August 2024. Read the full ...

8. ctv.veeva.com ctv.veeva.com/study/moda-flx-hemodialysis-system-under-professional-care-settings-by-trained-individuals-and-at-home-by

Moda-flx Hemodialysis System™ Under Professional Care ... The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care ...