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

NCT04868643 | Withdrawn DMC FDA Device

• 1 other identifier: DIAL-DIMI-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. The schedule will consist of four phases and the number of sessions per week will be prescribed the same throughout Phase 1 to 4.

Conditions

ESRD; Hemodialysis

Keywords

Home Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Delivery of a standardized weekly Kt/V based on lab data.

  6 weeks

Study Arms (2)

In-Center arm

OTHER

Subjects undergo In-Center treatment in Phase 2 as defined.

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.

Device: The DIMI Renal Replacement Therapy (RRT) System

Interventions

The DIMI Renal Replacement Therapy (RRT) System DEVICE

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.

In-Center arm; In-Home arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dialco Medical Inc.: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Replacement Therapy; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share