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

March 21, 2024 updated by: Dialco Medical Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.
  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.
  3. 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.
  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
  2. Subject is at least 18 years and less than 75 years of age.
  3. 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.
  4. 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.
  5. Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
  6. Subject has a documented psychosocial evaluation by a qualified social worker, treating physician or home hemodialysis nurse.
  7. 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.
  8. Subject has a home environment to perform hemodialysis that meets the criteria of Home Use Environment (defined in Section 15.1).

Exclusion Criteria:

  1. Subject has dementia or lacks capacity for self-care.
  2. Life expectancy less than 12 months from first study procedure.
  3. Subject is unable to understand or cooperate with hemodialysis nurse and dialysis care team.
  4. Subject has a documented history of non-adherence to dialysis treatment that would prevent successful completion of the study.
  5. Subject has had a recent major cardiovascular adverse event within the last 3 months.
  6. Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
  7. Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite medical therapy.
  8. Subject has symptomatic intra-dialytic hypotension requiring medical intervention in two of their last three treatments.
  9. Subject has an active infection requiring antibiotics within the last 7 days.
  10. Subject has fluid overload due to intractable ascites secondary to liver cirrhosis.
  11. 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).
  12. Subject is intolerant to heparin.
  13. Subject is seroreactive for Hepatitis B Surface Antigen.
  14. Subject has an active, life-threatening, rheumatologic disease.
  15. Subject has a history of adverse reactions to dialyzer membrane material.
  16. Subject is participating in another investigative drug or device clinical study related to Home Hemodialysis which conflicts with the execution of this study.
  17. Subject is expected to receive a kidney transplant from any donor organ in the next 6 months.
  18. Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
  19. Any other condition that the Investigator feels would prevent the Subject from being a suitable candidate for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: In-Center arm
Subjects undergo In-Center treatment in Phase 2 as defined.
Device: The DIMI Renal Replacement Therapy (RRT) System
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.
Other: In-Home arm

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delivery of a standardized weekly Kt/V based on lab data.
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dialco Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIAL-DIMI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently there is no plan for IPD sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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