NCT06613568 · Diality Inc.
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
What this study is about
The purpose of this study is to evaluate the safety and effectiveness of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
View original scientific 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
Interventions
DEVICE
Moda-flx Hemodialysis System™
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
Primary outcome measures
Weekly Standardized Dialysis Adequacy
Time frame: Up to 10 weeks per period
Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings
Adverse Event (AE) Rate
Time frame: Up to 10 weeks per period
The adverse event (AE) rate: defined as the number of Study Emergent AEs per 100 dialysis treatments occurring in the At Home period of the study, compared with those occurring during the Professional Care period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 (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 Screening Period
- 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 Screening
- Can successfully complete a Skills and Comprehension 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:
- Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
- Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
- 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
- Participant had an average ultrafiltration rate \> 13 mL/kg/hour during the last 2 weeks prior to Screening, per medical records.
- Had a significant cardiovascular adverse event within the last 90 days prior to Screening.
Where
- San Dimas, California
- New Hyde Park, New York
- Knoxville, Tennessee
- Houston, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations