No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Diality Inc. · Industry
Who this trial is looking for
This trial is looking for adults with end stage kidney disease who have stable kidney function and can learn how to use a new hemodialysis system. Participants will either use the system under professional care or at home with a trained care partner.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with end stage kidney disease.
I have stable kidney function with adequate dialysis.
I have a well-functioning and stable access for dialysis.
I can complete a skills assessment with a care partner.
You may not be able to join if
My hemoglobin level is below 9 g/dL.
I have had serious low blood pressure during dialysis treatments.
I have a history of not following dialysis therapy that could affect the study.
My average fluid removal rate has been too high in the last 2 weeks.
I have experienced a significant heart problem in the last 90 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Eligibility Criteria
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…
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:
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
* 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.
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