Quanta Home Run Trial

NCT04975880 | Completed Results DMC FDA Device

• 1 other identifier: 02-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Renal Failure

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Mean Standardized Weekly Kt/V (Efficacy)

  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

  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 Outcomes (1)

• Rate of Serious Adverse Events (SAEs) Per 100 Treatments.

  4-8 weeks in the clinic training phase and 8 weeks during the home phase.

Study Arms (1)

Hemodialysis Treatments

OTHER

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

Interventions

SC+ Hemodialysis System DEVICE

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.

Hemodialysis Treatments

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of a written informed consent form signed by the participant
• Age between 18 and 80 years at time of enrollment
• A care partner must be available for training on SC+ and to be present in the home during all home hemodialysis sessions
• 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
• 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
• 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
• 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.
• 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
• Participant or care partner are capable of being trained to use the machine and troubleshoot should an alarm situation occur
• In the opinion of the treating physician, the subject is able to participate in the trial in terms of social factors and personal functioning
• Acceptable physical ability of the participant and/or care partner to perform the hemodialysis treatment at home
• Financial coverage for treatment costs by Medicare, Medicaid, private insurance, or other arrangement acceptable to participant

You may not qualify if:

• Pregnant or trying to become pregnant (women of childbearing potential must use medically accepted contraceptive measures)
• Predicted life expectancy of less than 12 months from first study procedure
• Major cardiovascular adverse event in the 3 months prior to screening
• Fluid overload due to intractable ascites secondary to liver cirrhosis
• Uncontrolled or unstable blood pressure (systolic BP outside the range 90 to 180 mmHg)
• Unstable coronary artery disease
• New York Class III or IV heart failure, or ejection fraction less than 30%
• Participation in other clinical studies that may interfere with the current protocol
• Known problems with coagulation
• Active, life-threatening, rheumatologic disease.
• Hematocrit less than 28% at enrollment
• Hemoglobin less than 9 g/dL at enrollment
• Suffering from active severe infection
• Seroreactive for hepatitis B surface antigen
• Suffering from active malignancy with expected deteriorating course within 6-12 months

Sponsors & Collaborators

• Quanta Dialysis Technologies Ltd: lead

Study Sites (13)

Capital Nephrology Medical Group

Sacramento, California, 95825, United States

Location

Home Dialysis Therapies of San Diego / UCSD

San Diego, California, 92131, United States

Location

Satellite WellBound

San Leandro, California, 94577, United States

Location

Satellite - WellBound

San Mateo, California, 94403, United States

Location

Satellite - WellBound

Santa Rosa, California, 95407, United States

Location

High Desert Nephrology Medical Group

Victorville, California, 92392, United States

Location

Ocala RKCHD At Home

Ocala, Florida, 32724, United States

Location

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904, United States

Location

DaVita Home Dialysis of Indianapolis

Indianapolis, Indiana, 46260, United States

Location

New Hyde Park Dialysis Center

New Hyde Park, New York, 11040, United States

Location

Hypertension & Kidney Specialists

Lancaster, Pennsylvania, 17604, United States

Location

aQua Research Institute, LLC

Houston, Texas, 77058, United States

Location

Northwest Kidney Centers

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Paul Komenda
• Organization: Quanta Dialysis Technologies

paul.komenda@quantadt.com

(204) 510-5219

Study Officials

• Paul Komenda, MD

  Quanta Dialysis Technology

  STUDY DIRECTOR

• Christopher T Chan, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following enrollment participants will begin hemodialysis treatments on the SC+ machine on a prescription of four-hour treatments, three times per week or per facility standard for training within a hemodialysis facility for a minimum of 4 weeks. During this time, both patients and caregivers will undergo extensive training and competency sign off on all aspects of safely administering hemodialysis treatment in the home. This 4 week period can be extended week by week to a maximum of 8 weeks until competency sign off is achieved. Upon completion of training, a 1 week transition period will occur followed by the home hemodialysis phase (test phase) which consists of 8 weeks of treatments performed 4 times per week, 3.5 hours each treatment in the participant's home setting by the participant or their care partner.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 26, 2021
• Study Start: November 18, 2021
• Primary Completion: October 30, 2023
• Study Completion: November 27, 2024
• Last Updated: December 19, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)