The Evaluation of the DIMI RRT System In-Center to Demonstrate Safety and Usability in the Home Environment

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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ESRD, Hemodialysis

Intervention / Treatment
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* Device: The DIMI Renal Replacement Therapy (RRT) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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%. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: In-Center arm<br>Subjects undergo In-Center treatment in Phase 2 as defined. | Device: The DIMI Renal Replacement Therapy (RRT) System<br>* 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.<br>|
| Other: In-Home arm<br>Subjects undergo In-Home treatments in Phase 4 as defined. Subjects in Phase 2 and Phase 4 will be the same. | Device: The DIMI Renal Replacement Therapy (RRT) System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Hemodialysis