Quanta Home Run Trial

December 4, 2024 updated by: Quanta Dialysis Technologies Ltd

A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis

The purpose of this study is to determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.

Study Overview

Status

Status

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

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

This clinical trial is being conducted to evaluate the Quanta SC+ hemodialysis System for home use by patients with established kidney failure. A dialysis prescription of 3 sessions per week, 4 hours per session, or facility standard will be provided during the in-clinic training period, followed by the home period with a dialysis prescription of 4 sessions per week, 3.5 hours per session.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

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.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95825
        • Capital Nephrology Medical Group
      • San Diego, California, United States, 92131
        • Home Dialysis Therapies of San Diego / UCSD
      • San Leandro, California, United States, 94577
        • Satellite WellBound
      • San Mateo, California, United States, 94403
        • Satellite - WellBound
      • Santa Rosa, California, United States, 95407
        • Satellite - WellBound
      • Victorville, California, United States, 92392
        • High Desert Nephrology Medical Group
    • Florida
      • Ocala, Florida, United States, 32724
        • Ocala RKCHD At Home
    • Georgia
      • Augusta, Georgia, United States, 30904
        • Southeastern Clinical Research Institute, LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Davita Home Dialysis of Indianapolis
    • New York
      • New Hyde Park, New York, United States, 11040
        • New Hyde Park Dialysis Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Hypertension & Kidney Specialists
    • Texas
      • Houston, Texas, United States, 77058
        • aQua Research Institute, LLC
    • Washington
      • Seattle, Washington, United States, 98122
        • Northwest Kidney Centers

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of a written informed consent form signed by the participant
  2. Age between 18 and 80 years at time of enrollment
  3. A care partner must be available for training on SC+ and to be present in the home during all home hemodialysis sessions
  4. Participants should be either receiving regular, facility-based hemodialysis therapy for at least 90 days, or in the case of peritoneal patients transitioning to hemodialysis, at least 90 days, or performing home dialysis (with any frequency) for at least 90 days and willing to return to facility for purpose of study, and should be clinically stable and deemed suitable for home dialysis in the opinion of the principal investigator
  5. Willing to accept a dialysis prescription of 3 sessions per week, 4 hours each session or facility standard during in-clinic visits; 4 sessions, 3.5 hours each session during in-home sessions
  6. In the opinion of the Investigator, participant has well-functioning and stable vascular access (tunneled, central venous catheter, arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min
  7. Home environment is adequate to ensure that appropriate electrical connections and water supply necessary for the use and storage of the device as assessed by Quanta prior to subject C1 visit. Also ensure that cellular signal and/or WIFI capacity is adequate.
  8. Participant or care partner are capable of understanding the nature of procedures and requirements of the study protocol and of home-based hemodialysis, and are willing and capable of complying with protocol and returning to treatment center as stated in protocol
  9. Participant or care partner are capable of being trained to use the machine and troubleshoot should an alarm situation occur
  10. In the opinion of the treating physician, the subject is able to participate in the trial in terms of social factors and personal functioning
  11. Acceptable physical ability of the participant and/or care partner to perform the hemodialysis treatment at home
  12. Financial coverage for treatment costs by Medicare, Medicaid, private insurance, or other arrangement acceptable to participant

Exclusion Criteria:

  1. Pregnant or trying to become pregnant (women of childbearing potential must use medically accepted contraceptive measures)
  2. Predicted life expectancy of less than 12 months from first study procedure
  3. Major cardiovascular adverse event in the 3 months prior to screening
  4. Fluid overload due to intractable ascites secondary to liver cirrhosis
  5. Uncontrolled or unstable blood pressure (systolic BP outside the range 90 to 180 mmHg)
  6. Unstable coronary artery disease
  7. New York Class III or IV heart failure, or ejection fraction less than 30%
  8. Participation in other clinical studies that may interfere with the current protocol
  9. Known problems with coagulation
  10. Active, life-threatening, rheumatologic disease.
  11. Hematocrit less than 28% at enrollment
  12. Hemoglobin less than 9 g/dL at enrollment
  13. Suffering from active severe infection
  14. Seroreactive for hepatitis B surface antigen
  15. Suffering from active malignancy with expected deteriorating course within 6-12 months
  16. History of severe reactions to dialyzer membrane material
  17. Expected to receive an organ transplant during the course of the study
  18. Have dementia or inability to understand procedures
  19. Lack an ability for self-care
  20. Are non-adherent to their current dialysis treatments
  21. Experience intra-dialytic hypotension defined as a decrease in systolic blood pressure of greater than or equal to 20 mmHg or a decrease in mean arterial pressure of greater than or equal to 10 mmHg provided that the decrease is associated with clinical events (symptoms) and the need for an intervention (ultrafiltration turned off, bolus of fluid) in 3 of 5 previous treatments
  22. Is intolerant to heparin
  23. Considered in the investigator's opinion to be clinically unstable for any other reason
  24. Undergoing outpatient dialysis for the treatment of acute kidney injury (AKI)

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: N/A
  • Interventional Model: Single Group 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: Hemodialysis Treatments
All subjects will receive hemodialysis treatments using the SC+ machine for all phases of the trial including in-clinic training, transition, and in the home setting.
Device: SC+ Hemodialysis System
Following the in-clinic training phase and one week transition, the intervention of self or care partner hemodialysis delivered in the home setting will occur for 8 weeks.

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
Mean Standardized Weekly Kt/V (Efficacy)
Time Frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
The primary effectiveness endpoint was the delivery of a mean standardized weekly Kt/V of greater than or equal to 2.1 in both the clinic phase and the home phase. The weekly standard Kt/V is used to assess dialysis effectiveness by taking into account the clearance provided by individual treatments and the number of times per week the participant treated. The weekly standardized Kt/V is calculated using K (clearance of urea), T (treatment time), and V (urea distribution volume). Current practice guidelines include achieving a minimum result of 2.1 with a target of achieving 2.3, with higher values representing better outcomes. A theoretical range for the minimum and maximum standardized weekly Kt/V does not exist.
4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Adverse Event Rate
Time Frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.

Adverse event rate: the number of adverse events per 100 treatments that occurred during the study, as defined by:

  • Serious adverse event (SAE)
  • Allergic reaction: type A, anaphylactoid or type B dialyzer reactions to dialyzer, blood tubing, or chemical disinfectant.
  • Blood loss: resulting in hemodynamic compromise that led to death, transfusion, or fluid resuscitation with greater than 1 liter of crystalloid IV fluids.
  • Hemolytic reaction: due to disinfectant exposure, dialysate temperature, mechanical failure, or other device related causes.
  • Infection: related to hemodialysis catheter, its tunnel or exit site, arteriovenous fistula (AVF), or arteriovenous graft (AVG).
  • Intradialytic event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure.
  • Vascular access complication
  • Pyrogenic reaction
4-8 weeks in the clinic training phase and 8 weeks during the home phase.

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
Rate of Serious Adverse Events (SAEs) Per 100 Treatments.
Time Frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Number of SAEs per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion
4-8 weeks in the clinic training phase and 8 weeks during the home phase.

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.
Quanta Dialysis Technologies Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paul Komenda, MD, Quanta Dialysis Technology
  • Principal Investigator: Christopher T Chan, MD, University of Toronto

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 (Actual)

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.
November 18, 2021

Primary Completion (Actual)

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.
October 30, 2023

Study Completion (Actual)

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.
November 27, 2024

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).
July 14, 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.
July 14, 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.
July 26, 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 25, 2025

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.
December 4, 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.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 02-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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