Trial Outcomes & Findings for Quanta Home Run Trial (NCT NCT04975880)

Last Updated: 2024-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

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

Results posted on

2024-12-19

Participant Flow

3 participants withdrew consent prior to beginning the clinic phase.

Participant milestones

Participant milestones
Measure	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. SC+ Hemodialysis System: Following the in-clinic training phase (lasting 4 to 8 weeks) and one week transition, the intervention of self or care partner hemodialysis delivered in the home setting will occur for 8 weeks.
Clinic Training Phase STARTED	43
Clinic Training Phase Evaluable Population	35
Clinic Training Phase COMPLETED	35
Clinic Training Phase NOT COMPLETED	8
Transition Phase STARTED	35
Transition Phase Evaluable Population	35
Transition Phase COMPLETED	35
Transition Phase NOT COMPLETED	0
Home Hemodialysis Phase STARTED	35
Home Hemodialysis Phase Evaluable Population	34
Home Hemodialysis Phase COMPLETED	31
Home Hemodialysis Phase NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quanta Home Run Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evaluable Population n=34 Participants The Evaluable Population was defined as those participants who completed at least 75% of the treatments required by the protocol. The Evaluable Population of this study was 34 participants.
Age, Continuous	53.9 years STANDARD_DEVIATION 14.06 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants
Vascular Access Type Fistula	19 Participants n=5 Participants
Vascular Access Type Central Line	9 Participants n=5 Participants
Vascular Access Type Graft	6 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Clinic Training Phase n=34 Participants Clinic personnel administered treatments while training the participant and caregiver in a clinic setting with a prescription of 3 treatments per week, 4 hours per treatment, using the SC+ machine.	Home Hemodialysis Phase n=34 Participants Participants and caregivers administered treatments in the home with a prescription of 4 treatments per week, 3.5 hours for each treatment.
Mean Standardized Weekly Kt/V (Efficacy)	2.4 Kt/V Standard Deviation 0.04	3.0 Kt/V Standard Deviation 0.03

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Clinic Training Phase n=34 Participants Clinic personnel administered treatments while training the participant and caregiver in a clinic setting with a prescription of 3 treatments per week, 4 hours per treatment, using the SC+ machine.	Home Hemodialysis Phase n=34 Participants Participants and caregivers administered treatments in the home with a prescription of 4 treatments per week, 3.5 hours for each treatment.
Adverse Event Rate	6.3 Events per 100 treatments Interval 3.02 to 9.6	5.2 Events per 100 treatments Interval 3.29 to 7.11

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Clinic Training Phase n=34 Participants Clinic personnel administered treatments while training the participant and caregiver in a clinic setting with a prescription of 3 treatments per week, 4 hours per treatment, using the SC+ machine.	Home Hemodialysis Phase n=34 Participants Participants and caregivers administered treatments in the home with a prescription of 4 treatments per week, 3.5 hours for each treatment.
Rate of Serious Adverse Events (SAEs) Per 100 Treatments.	0.6 Events per 100 treatments Interval 0.02 to 1.14	0.8 Events per 100 treatments Interval 0.3 to 1.24

Adverse Events

Clinic Training Phase

Serious events: 5 serious events

Other events: 3 other events

Deaths: 1 deaths

Transition Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home Hemodialysis Phase

Serious events: 8 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Clinic Training Phase n=43 participants at risk Clinic personnel administered treatments while training the participant and caregiver in a clinic setting with a prescription of 3 treatments per week, 4 hours per treatment, using the SC+ machine.	Transition Phase n=35 participants at risk Participants and caregivers administered treatments in the home under the supervision of clinic personnel for 1 week.	Home Hemodialysis Phase n=35 participants at risk Participants and caregivers administered treatments in the home with a prescription of 4 treatments per week, 3.5 hours for each treatment.
Blood and lymphatic system disorders Anemia	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	2.9% 1/35 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
General disorders Cardiac Death	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	2.9% 1/35 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
General disorders Chest Pain	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	5.7% 2/35 • Number of events 2 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
General disorders Systemic Inflammatory Response Syndrome	2.3% 1/43 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Infections and infestations Bacteremia	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	2.9% 1/35 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Infections and infestations Covid-19	2.3% 1/43 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Infections and infestations Diabetic Foot Infection	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	2.9% 1/35 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Infections and infestations Scrotal Abscess	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	2.9% 1/35 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Infections and infestations Urinary Tract Infection Bacterial	2.3% 1/43 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Metabolism and nutrition disorders Electrolyte Imbalance	2.3% 1/43 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Edema	0.00% 0/43 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	2.9% 1/35 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Vascular disorders Hypotension	2.3% 1/43 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.

Other adverse events

Other adverse events
Measure	Clinic Training Phase n=43 participants at risk Clinic personnel administered treatments while training the participant and caregiver in a clinic setting with a prescription of 3 treatments per week, 4 hours per treatment, using the SC+ machine.	Transition Phase n=35 participants at risk Participants and caregivers administered treatments in the home under the supervision of clinic personnel for 1 week.	Home Hemodialysis Phase n=35 participants at risk Participants and caregivers administered treatments in the home with a prescription of 4 treatments per week, 3.5 hours for each treatment.
Investigations Laboratory Test Abnormal	2.3% 1/43 • Number of events 1 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.
Metabolism and nutrition disorders Electrolyte Imbalance	4.7% 2/43 • Number of events 2 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.	0.00% 0/35 • Adverse events were collected during all phases of the primary study: Clinical training (4-8 weeks), transition phase (1 week), and the Home Hemodialysis Phase (8 weeks). Adverse events were collected for a maximum of 17 weeks. An independent safety and clinical events committee (SCEC) was created, chartered, and maintained while any adverse events were being collected or participants were receiving study treatment to oversee trial safety. Adverse events were collected directly from participants using open-ended questions, through clinic progress notes, and other medical records obtained by research sites.

Additional Information

Dr. Paul Komenda

Quanta Dialysis Technologies

Phone: (204) 510-5219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Before publishing or presenting trial results, the Principal Investigator is to submit copies of any Proposed Manuscripts to Sponsor at least 60 days in advance of submission. If Sponsor determines that the publication or presentation would be detrimental to its or its affiliates' intellectual property interests, an additional 90 days can be instituted to allow Sponsor to take appropriate steps to protect its or its affiliates' intellectual property interests.
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Restriction type: OTHER