End Stage Renal DiseaseNCT06581393
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
A study testing Moda-flx Hemodialysis System in people with End Stage Renal Disease and End Stage Renal Disease on Dialysis, run by Diality Inc. at 1 site in United States.
Trial summary
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, End Stage Renal Disease on Dialysis, 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 consent.
- Must sign the informed consent and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Understand the nature of the procedures and the requirements of the Study.
Who cannot join
- Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist.
- In the opinion of the treating nephrologist, any other reason in which study participation would result in undue risk, including but not limited to protocol required prescription parameters.
- Are contraindicated for or not indicated to use the Moda-flx Hemodialysis System™ according to the Instructions For Use (IFU).
Trial locations and contacts
1 site in 1 country.
United States1 site
North America Research Institute
Ontario, California, 91762
About this study
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting.
- Being tested
- Moda-flx Hemodialysis System
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moda-flx Hemodialysis SystemDevice
All participants will complete up to 4 dialysis treatments on the Moda-flx Hemodialysis System over a period of up to 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Professional Care in an In-Center Hemodialysis Setting | Experimental | Hemodialysis using the Moda-flx Hemodialysis System Receives: Device: Moda-flx Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-Pool Standardized Dialysis Adequacy
Single-pool standardized dialysis adequacy (spKt/V) will be measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. spKt/V values of ≥ 1.2 are regarded as being adequate.
Measured: Samples will be collected before and after each dialysis treatment at Visit 1, Visit 2, Visit 3 and at Visit 4 over a two week period
Changes in Blood Chemistry
Changes in overall blood chemistry laboratory levels from Visit 1 to Visit 4.
Measured: Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Changes in Complete Blood Count
Changes in overall complete blood count levels from Visit 1 to Visit 4.
Measured: Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Changes in Iron Studies
Changes in overall iron studies levels from Visit 1 to Visit 4.
Measured: Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start9 Dec 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diality Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581393
- Sponsor's protocol ID
- DIA-NSR-001
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 22 Jun 2025
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
- ClinicalTrials.gov ID
- NCT06581393
- Acronym / sponsor ID
- DIA-NSR-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Diality Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 3 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.
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting.
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 in an In-Center Hemodialysis Setting | Experimental | Device: Moda-flx Hemodialysis SystemHemodialysis using the Moda-flx Hemodialysis System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 consent.
- Must sign the informed consent and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Understand the nature of the procedures and the requirements of the Study.
Key exclusion criteria (3 listed)
- Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist.
- In the opinion of the treating nephrologist, any other reason in which study participation would result in undue risk, including but not limited to protocol required prescription parameters.
- Are contraindicated for or not indicated to use the Moda-flx Hemodialysis System™ according to the Instructions For Use (IFU).
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 SystemAll participants will complete up to 4 dialysis treatments on the Moda-flx Hemodialysis System over a period of up to 2 weeks. | Device | Professional Care in an In-Center Hemodialysis Setting |
Primary outcome
Single-Pool Standardized Dialysis Adequacy
Time frame: Samples will be collected before and after each dialysis treatment at Visit 1, Visit 2, Visit 3 and at Visit 4 over a two week period
Single-pool standardized dialysis adequacy (spKt/V) will be measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. spKt/V values of ≥ 1.2 are regarded as being adequate.
Changes in Blood Chemistry
Time frame: Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Changes in overall blood chemistry laboratory levels from Visit 1 to Visit 4.
Changes in Complete Blood Count
Time frame: Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Changes in overall complete blood count levels from Visit 1 to Visit 4.
Changes in Iron Studies
Time frame: Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period
Changes in overall iron studies levels from Visit 1 to Visit 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Renal Disease and End Stage Renal Disease on Dialysis, run by Diality Inc. at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-Pool Standardized Dialysis Adequacy (time frame: Samples will be collected before and after each dialysis treatment at Visit 1, Visit 2, Visit 3 and at Visit 4 over a two week period). The study lists 4 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 22 Jun 2025.