Quanta Home Run Trial

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: Active, not recruiting
• Conditions: Renal Failure
• Intervention / Treatment: Device: SC+ Hemodialysis System

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: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Bismarck, RN; Phone Number: +1-978-998-9090; Email: lisa.bismarck@quantadt.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean Standardized Weekly Kt/V (Efficacy)	Mean standardized weekly Kt/V greater than or equal to 2.1, using a hemodialysis prescription of 4 sessions per week for 3.5 hours per session, measured for dialysis delivered during the home portion of the study.	8 weeks per period
Adverse Event Rate	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; Intradialytic hypotension	8 weeks per period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SAEs and device-related SAEs	Number of SAEs per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion; Number of device-related SAEs per 100 treatments in the in-clinic portion of the study compared with those occurring in the home portion; Number of adverse events per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion; Additional adverse events of special interest:Air in blood tubing that cannot be resolved through usual procedure30 minutes post dialysis elevated systolic blood pressure > 180 mmHg or low systolic blood pressure < 90 mmHg on two consistent treatmentsSignificantly elevated (<100 mmHg or > 250 mmHg) arterial or venous pressures in 3 consecutive sessions Specific hematology laboratory values will be collected and compared to target ranges from clinical practice guidelines.	8 weeks per period

Collaborators and Investigators

• Sponsor: Quanta Dialysis Technologies Ltd
• Investigators: Study Director: Paul Komenda, MD, Quanta Dialysis Technology; Principal Investigator: Christopher T Chan, MD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): October 30, 2023
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID 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