Quanta Home Run Trial

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04975880
• Other study ID #: 02-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Quanta Dialysis Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: October 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Southeastern Clinical Research Institute, LLC	Augusta	Georgia
United States	aQua Research Institute, LLC	Houston	Texas
United States	DaVita Home Dialysis of Indianapolis	Indianapolis	Indiana
United States	Hypertension & Kidney Specialists	Lancaster	Pennsylvania
United States	New Hyde Park Dialysis Center	New Hyde Park	New York
United States	Ocala RKCHD At Home	Ocala	Florida
United States	Capital Nephrology Medical Group	Sacramento	California
United States	Home Dialysis Therapies of San Diego / UCSD	San Diego	California
United States	Satellite WellBound	San Leandro	California
United States	Satellite - WellBound	San Mateo	California
United States	Satellite - WellBound	Santa Rosa	California
United States	Northwest Kidney Centers	Seattle	Washington
United States	High Desert Nephrology Medical Group	Victorville	California

Sponsors (1)

Lead Sponsor	Collaborator
Quanta Dialysis Technologies Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 procedure; 30 minutes post dialysis elevated systolic blood pressure > 180 mmHg or low systolic blood pressure < 90 mmHg on two consistent treatments; Significantly 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