End Stage Kidney DiseaseNCT06613568
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
A study testing Moda-flx Hemodialysis System™ in people with End Stage Kidney Disease, run by Diality Inc. at 5 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Moda-flx Hemodialysis System™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
aQua Research Institute, LLC
Houston, Texas, 77058
Rhea Sharma, 281-939-6516, rheas@aqua-ri.com
- Recruiting
Nephrology Associates of Knoxville
Knoxville, Tennessee, 37920
Benjamin Brooks, 865-323-3382, benjamin.brooks@dciinc.org
- Recruiting
New York Kidney Hypertension Medicine
New Hyde Park, New York, 11040
Muhammad Qureshi, MD, 718-483-7407, mqureshi@atlanticdialysis.com
- Recruiting
North America Research Institute
San Dimas, California, 91773
Molly Way, (800) 797-1695, mpruitt@nariresearch.com
- Recruiting
University of Washington
Seattle, Washington, 98104
Lori Linke, linkel@uw.edu
About this study
Official title: Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens
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
- End Stage Kidney Disease
- Being tested
- Moda-flx Hemodialysis System™
- Keywords
- Renal Disease, Hemodialysis Complication, Kidney Diseases, Dialysis, Renal Dialysis, Hemodialysis, Home, Renal Insufficiency, Kidney Failure, Chronic
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moda-flx Hemodialysis System™Device
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
| Study group | Role | What they receive |
|---|---|---|
| Professional Care and At Home | Experimental | Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting Receives: Device: Moda-flx Hemodialysis System™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Standardized Dialysis Adequacy
Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings
Measured: Up to 10 weeks per period
Adverse Event (AE) Rate
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.
Measured: Up to 10 weeks per period
Secondary outcomes (2)
Goal Ultrafiltration Volume
Compliance with fluid removal goals that are defined as:
Ultrafiltration (net fluid removal), such that the recorded value from the Moda-flx Hemodialysis System™ is within ± 100 mL/h or ± 250 mL (whichever is less) of set point during the treatment, based on the UF prescription.
Measured: Up to 10 weeks per period
Study Emergent Pre-Specified Adverse Events
Study Emergent Pre-Specified Adverse Eventss, categorized by study period (Professional Care and At Home) severity, device relationship and procedure relationship. Study-emergent Pre-Specified AEs are those AEs with an onset on or after the date of first treatment during the Run-In Period, which will be comprised of any of the following:
- A composite of:
- Serious Adverse Event
- Allergic Reaction
- Blood Loss
- Hemolytic Reaction
- Infection
- Intradialytic Event
- Vascular Access Complication
- Pyrogenic Reaction
Measured: Up to 10 weeks per period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start6 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diality Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia Silva, MD, Study director, Diality Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613568
- Sponsor's protocol ID
- DIA-HHD-001
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens
- ClinicalTrials.gov ID
- NCT06613568
- Acronym / sponsor ID
- DIA-HHD-001
- Conditions
- End Stage Kidney Disease
- Keywords
- Renal Disease, Hemodialysis Complication, Kidney Diseases, Dialysis, Renal Dialysis, Hemodialysis, Home, Renal Insufficiency, Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diality Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Professional Care and At Home | Experimental | Device: Moda-flx Hemodialysis System™Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moda-flx Hemodialysis System™The Moda-flx Hemodialysis System™ is a portable hemodialysis system | Device | Professional Care and At Home |
Primary outcome
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.
2 secondary outcomes
Goal Ultrafiltration Volume
Time frame: Up to 10 weeks per period
Study Emergent Pre-Specified Adverse Events
Time frame: Up to 10 weeks per period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Silva, MD study director
Diality Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moda-flx Hemodialysis System™ in people with End Stage Kidney Disease, run by Diality Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Gastauer (949-916-5851, HomeTrial@Diality.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Standardized Dialysis Adequacy (time frame: Up to 10 weeks per period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.