ESRDNCT04868643
The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment
A study testing The DIMI Renal Replacement Therapy (RRT) System in people with ESRD and Hemodialysis, run by Dialco Medical Inc..
Trial summary
This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study phases, according to the schedule outlined below. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESRD, Hemodialysis
- What is being tested?
- The DIMI Renal Replacement Therapy (RRT) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Aug 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Subject is at least 18 years and less than 75 years of age.
- Subject has identified an individual "Care Partner" to be trained and available as needed. Such Care Partner must be considered competent to train on the use of the device by the prescribing physician, and must commit to the trial.
- Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
- Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
- Subject has a documented psychosocial evaluation by a qualified social worker, treating physician or home hemodialysis nurse.
- Subject has no childbearing potential or has a negative pregnancy test within 7 days prior to the start of the first study treatment and will be utilizing medically acceptable means of contraception during the study period.
- Subject has a home environment to perform hemodialysis that meets the criteria of Home Use Environment (defined in Section 15.1).
Who cannot join
- Subject has dementia or lacks capacity for self-care.
- Life expectancy less than 12 months from first study procedure.
- Subject is unable to understand or cooperate with hemodialysis nurse and dialysis care team.
- Subject has a documented history of non-adherence to dialysis treatment that would prevent successful completion of the study.
- Subject has had a recent major cardiovascular adverse event within the last 3 months.
- Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
Show all 19Show fewer
- Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite medical therapy.
- Subject has symptomatic intra-dialytic hypotension requiring medical intervention in two of their last three treatments.
- Subject has an active infection requiring antibiotics within the last 7 days.
- Subject has fluid overload due to intractable ascites secondary to liver cirrhosis.
- Subject has uncontrolled blood pressure (e.g. sustained/persistent pre- dialysis systolic blood pressure greater than 180 mmHg despite maximal medical therapy in two of the last three treatments).
- Subject is intolerant to heparin.
- Subject is seroreactive for Hepatitis B Surface Antigen.
- Subject has an active, life-threatening, rheumatologic disease.
- Subject has a history of adverse reactions to dialyzer membrane material.
- Subject is participating in another investigative drug or device clinical study related to Home Hemodialysis which conflicts with the execution of this study.
- Subject is expected to receive a kidney transplant from any donor organ in the next 6 months.
- Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
- Any other condition that the Investigator feels would prevent the Subject from being a suitable candidate for inclusion in the study.
About this study
Official title: A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the DIMI Renal Replacement Therapy (RRT) System In-Center by Trained Dialysis Nurses and In-Home by Trained Care Partners and Patients With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens.
This is a prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study phases, according to the schedule outlined below. The schedule will consist of four phases and the number of sessions per week will be prescribed the same throughout Phase 1 to 4.
Read the detailed description
- Phase 1: Run-in. Duration: 2 weeks. Potential Subjects will undergo dialysis treatments 3 - 5 times per week for up to 2 weeks In-Center. Treatments will be administered by study staff during this phase. Study eligibility will be assessed for both the potential Subject and their Care Partner after completion of the run-in period. Potential subjects and Care Partners who meet all eligibility criteria will be invited to Phase 2.
- Phase 2: In-Center Treatment. Duration: 6 weeks. Subjects will undergo dialysis treatments 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) In-Center. Treatments will be administered by study staff.
- Phase 3: Cross-over Period from In-Center to In-Home environment. Duration: 4 weeks. Care Partners will undergo the DIMI training, then perform dialysis treatments on Subjects 3 - 5 times per week for approximately 4 weeks (for a total of 12 - 20 sessions). Treatments will be completed In-Center under the supervision of hemodialysis nurses and at the discretion of the investigator.
- Phase 4: In-Home Treatment. Duration: 6 weeks. Care Partners will perform dialysis treatments to the Subject 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) in a home environment.
- Conditions
- ESRD, Hemodialysis
- Being tested
- The DIMI Renal Replacement Therapy (RRT) System
- Keywords
- Home Hemodialysis
- 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.
The DIMI Renal Replacement Therapy (RRT) SystemDevice
To demonstrate that the safety and efficacy of the DIMI RRT remains consistent when used In-Center by trained dialysis nurses versus in an In-Home environment by trained Care Partners and Subjects.
| Study group | Role | What they receive |
|---|---|---|
| In-Center arm | Other | Subjects undergo In-Center treatment in Phase 2 as defined. Receives: Device: The DIMI Renal Replacement Therapy (RRT) System |
| In-Home arm | Other | Subjects undergo In-Home treatments in Phase 4 as defined.
Subjects in Phase 2 and Phase 4 will be the same. Receives: Device: The DIMI Renal Replacement Therapy (RRT) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of the prescribed fluid volume, defined as delivered volume that is at least 90% of prescribed volume at each in-home dialysis session.
The delivered volume is the total effluent volume (spent dialysate plus net ultrafiltrate) as measured by the device by means of 2 independent and calibrated electronic scales. The effluent volume is an effective means of assessing the usability of the machine in different environments and by different people, as any early interruption of treatment will result in a lower delivered volume.
Measured: 6 weeks
Secondary outcomes (1)
Delivery of a standardized weekly Kt/V based on lab data.
The secondary efficacy endpoint is the delivery of a standardized weekly Kt/V of greater than or equal to 2.1, that will be measured weekly. The standardized weekly Kt/V value will be computed by the Sponsor and included in the study database from laboratory data provided and recorded by the site via the Case Report Forms (CRFs).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study startJan 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: The company no longer wishes to pursue this IDE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dialco Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868643
- Sponsor's protocol ID
- DIAL-DIMI-001
- Status last verified
- Mar 2024
- First submitted
- 22 Apr 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Currently there is no plan for IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the DIMI Renal Replacement Therapy (RRT) System In-Center by Trained Dialysis Nurses and In-Home by Trained Care Partners and Patients With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens.
- ClinicalTrials.gov ID
- NCT04868643
- Acronym / sponsor ID
- DIAL-DIMI-001
- Conditions
- ESRD, Hemodialysis
- Keywords
- Home Hemodialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company no longer wishes to pursue this IDE
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dialco Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 May 2021 (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 prospective, multicenter, open label, non-randomized, cross-over study. Subjects will be enrolled in the trial for approximately 18 weeks and will use the DIMI RRT System for their dialysis treatments for all study phases, according to the schedule outlined below. The schedule will consist of four phases and the number of sessions per week will be prescribed the same throughout Phase 1 to 4.
Detailed description
- Phase 1: Run-in. Duration: 2 weeks. Potential Subjects will undergo dialysis treatments 3 - 5 times per week for up to 2 weeks In-Center. Treatments will be administered by study staff during this phase. Study eligibility will be assessed for both the potential Subject and their Care Partner after completion of the run-in period. Potential subjects and Care Partners who meet all eligibility criteria will be invited to Phase 2.
- Phase 2: In-Center Treatment. Duration: 6 weeks. Subjects will undergo dialysis treatments 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) In-Center. Treatments will be administered by study staff.
- Phase 3: Cross-over Period from In-Center to In-Home environment. Duration: 4 weeks. Care Partners will undergo the DIMI training, then perform dialysis treatments on Subjects 3 - 5 times per week for approximately 4 weeks (for a total of 12 - 20 sessions). Treatments will be completed In-Center under the supervision of hemodialysis nurses and at the discretion of the investigator.
- Phase 4: In-Home Treatment. Duration: 6 weeks. Care Partners will perform dialysis treatments to the Subject 3 - 5 times per week for approximately 6 weeks (for a total of 18 - 30 sessions) in a home environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Center arm | Other | Device: The DIMI Renal Replacement Therapy (RRT) SystemSubjects undergo In-Center treatment in Phase 2 as defined. |
| In-Home arm | Other | Device: The DIMI Renal Replacement Therapy (RRT) SystemSubjects undergo In-Home treatments in Phase 4 as defined. Subjects in Phase 2 and Phase 4 will be the same. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Subject is at least 18 years and less than 75 years of age.
- Subject has identified an individual "Care Partner" to be trained and available as needed. Such Care Partner must be considered competent to train on the use of the device by the prescribing physician, and must commit to the trial.
- Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
- Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
Key exclusion criteria (19 listed)
- Subject has dementia or lacks capacity for self-care.
- Life expectancy less than 12 months from first study procedure.
- Subject is unable to understand or cooperate with hemodialysis nurse and dialysis care team.
- Subject has a documented history of non-adherence to dialysis treatment that would prevent successful completion of the study.
- Subject has had a recent major cardiovascular adverse event within the last 3 months.
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 |
|---|---|---|
| The DIMI Renal Replacement Therapy (RRT) SystemTo demonstrate that the safety and efficacy of the DIMI RRT remains consistent when used In-Center by trained dialysis nurses versus in an In-Home environment by trained Care Partners and Subjects. | Device | In-Center arm, In-Home arm |
Primary outcome
Delivery of the prescribed fluid volume, defined as delivered volume that is at least 90% of prescribed volume at each in-home dialysis session.
Time frame: 6 weeks
The delivered volume is the total effluent volume (spent dialysate plus net ultrafiltrate) as measured by the device by means of 2 independent and calibrated electronic scales. The effluent volume is an effective means of assessing the usability of the machine in different environments and by different people, as any early interruption of treatment will result in a lower delivered volume.
1 secondary outcome
Delivery of a standardized weekly Kt/V based on lab data.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No. Currently there is no plan for IPD sharing
Related trials for ESRD
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Questions about this trial
What is this clinical trial studying?
A study testing The DIMI Renal Replacement Therapy (RRT) System in people with ESRD and Hemodialysis, run by Dialco Medical Inc..
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 8 inclusion and 19 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: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Delivery of the prescribed fluid volume, defined as delivered volume that is at least 90% of prescribed volume at each in-home dialysis session. (time frame: 6 weeks). 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 Mar 2024.