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

Launched by DIALITY INC. · Sep 23, 2024

Keywords

ClinConnect Summary

The Moda-flx Hemodialysis System™ clinical trial is studying a new way to provide hemodialysis, a treatment for people with end stage kidney disease (ESKD). The goal is to evaluate how safe and effective this system is when used by trained healthcare professionals in a clinic and also by patients at home with the help of a care partner. This trial is not yet recruiting participants, but when it does, it will include adults aged 18 to 75 who have been stable on dialysis and have a good access point for their blood flow.

To participate, individuals must meet certain criteria, including being diagnosed with ESKD and having a well-functioning vascular access. They should also be able to successfully complete a skills assessment with their care partner after training. However, those with certain medical issues, like low hemoglobin levels or a history of serious blood pressure problems during dialysis, will not be eligible. Participants can expect to learn how to use the Moda-flx system safely, both in a professional setting and at home, making their treatment more flexible and potentially more convenient.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Are between 18 and 75 years of age and Care Partner is at least 18 years of age at the time of signing consent
• • 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 the end of the Run-In Period
• • In the opinion of the Investigator, have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of the Run-In Period
• • In the opinion of the Investigator, can successfully complete a Skills Assessment with a Care Partner prior to the completion of the Training Period
• Exclusion Criteria:
• • Hgb level of \< 9 g/dL at Screening
• * Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:
• • 1. Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
• • 2. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
• • 3. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
• • Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study