Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
Launched by DIALITY INC. · Sep 23, 2024
Trial Information
Current as of July 02, 2025
Not yet recruiting
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
About Diality Inc.
Diality Inc. is an innovative clinical trial sponsor dedicated to advancing the development of transformative therapies through cutting-edge research and technology. With a focus on enhancing patient outcomes, Diality leverages a robust portfolio of clinical programs and partnerships to accelerate the delivery of novel treatments across various therapeutic areas. Committed to rigorous scientific standards and ethical practices, Diality fosters collaboration with healthcare professionals and regulatory bodies to ensure the highest quality of clinical trials, ultimately aiming to improve health care solutions for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Jennifer Joe, MD
Study Chair
Diality Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported