Actively Recruiting
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
Led by Diality Inc. · Updated on 2025-11-10
50
Participants Needed
4
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are between 18 and 80 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 (spKt/V 21 1.2 OR stdKt/V 21 2.1) and deemed stable by their nephrologist.
- Have a well-functioning, stable vascular access (tunneled central venous catheter, arteriovenous fistula, or graft) allowing blood flow of at least 300 ml/min.
- Can successfully complete a Skills and Comprehension Assessment with a Care Partner before completing training.
You will not qualify if you...
- Hemoglobin level below 9 g/dL at screening.
- Symptomatic intradialytic hypotension requiring medical intervention in at least two treatments during the Run-In period, defined by specific blood pressure criteria.
- Documented history of not following dialysis therapy that would prevent study completion.
- Average ultrafiltration rate greater than 13 mL/kg/hour during the last 2 weeks before screening.
- Significant cardiovascular adverse event within 90 days prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
North America Research Institute
San Dimas, California, United States, 91773
Actively Recruiting
2
Nephrology Associates of Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
3
aQua Research Institute, LLC
Houston, Texas, United States, 77058
Actively Recruiting
4
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
M
Michael Gastauer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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