End Stage Renal Disease
Conditions
Brief summary
The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.
Interventions
Sponsors
Outset Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be enrolled in the trial for approximately 21 weeks according to the following schedule: * Run-in, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 1 week * Treatment Period 1, In-Center - Subjects undergo study staff administered dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks) * In-Home Transition - Subjects undergo device training for the study, perform self-care dialysis 4 times/week for approximately 4 weeks, and are assessed for stability in the new care environment. * Treatment Period 2, In-Home - Subjects undergo self-care dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist. * Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
Exclusion criteria
* Life expectancy less than 12 months from first study procedure. * Subject has had a recent major cardiovascular adverse event within the last 3 months. * Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%. * Subject with fluid overload due to intractable ascites secondary to liver cirrhosis. * Subject has uncontrolled blood pressure. * Subject is intolerant to heparin. * Subject is seroreactive for Hepatitis B Surface Antigen. * Subject has an active, life-threatening, rheumatologic disease. * Subject has a history of adverse reactions to dialyzer membrane material. * Subject is expected to receive an organ transplant during the course of the study. * Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Standardized Dialysis Adequacy | 8 weeks per period | Weekly standardized dialysis adequacy (stdKt/V) was measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate. |
| Incidence of Pre-Specified Adverse Events | 8 weeks per period | All adverse events (AEs) observed in the trial were reviewed by an independent Clinical Events Committee (CEC). AEs adjudicated into the following pre-specified categories were included in the outcome measure: 1. Serious Adverse Event 2. Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant. 3. Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 4. Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes. 5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. 7. Vascular Access Complications 8. Pyrogenic Reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrafiltration Rate Success | 8 weeks per period | The Ultrafiltration (UF) rate was calculated using the following method: UF rate = (Fluid Removal Goal + Rinse Back Volume) / Treatment Duration. Where: Fluid Removal Goal = (Today's Weight - Prescribed Estimated Dry Weight) And: Rinse Back Volume = The volume of saline, 300mL, returned to the patient at the end of treatment. Each dialysis treatment was flagged as a success with respect to UF if the actual UF rate was within 10% of the prescribed UF rate. The mean (i.e., success proportion) and standard deviation were computed by treatment period across all subjects, where the denominator for the mean calculations was the total number of treatments in each treatment period for which the subjects contributed non-missing UF data. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at 8 dialysis centers throughout the U.S.
Pre-assignment details
A run-in period of 1 week (4 hemodialysis treatments) was required on the Tablo Hemodialysis System prior to the first period.
Participants by arm
| Arm | Count |
|---|---|
| Intention-To-Treat (ITT) Population The ITT population was defined as all participants who were enrolled and fulfilled inclusion criteria. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Transition Period | Death | 1 |
| Transition Period | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Intention-To-Treat (ITT) Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
| Vascular Access Type Catheter | 4 Participants |
| Vascular Access Type Fistula | 23 Participants |
| Vascular Access Type Graft | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 30 | 0 / 28 |
| other Total, other adverse events | 14 / 30 | 6 / 30 | 10 / 28 |
| serious Total, serious adverse events | 1 / 30 | 2 / 30 | 2 / 28 |
Outcome results
Primary
Incidence of Pre-Specified Adverse Events
All adverse events (AEs) observed in the trial were reviewed by an independent Clinical Events Committee (CEC). AEs adjudicated into the following pre-specified categories were included in the outcome measure: 1. Serious Adverse Event 2. Allergic Reaction: to dialyzer, blood tubing or chemical disinfectant. 3. Blood Loss: that leads to death, transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 4. Hemolytic Reaction: due to disinfectant exposure, dialysate temperature, mechanical failure or other device related causes. 5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. 7. Vascular Access Complications 8. Pyrogenic Reaction
Time frame: 8 weeks per period
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-Center | Incidence of Pre-Specified Adverse Events | 2 Adverse Events |
| In-Home | Incidence of Pre-Specified Adverse Events | 6 Adverse Events |
Primary
Weekly Standardized Dialysis Adequacy
Weekly standardized dialysis adequacy (stdKt/V) was measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
Time frame: 8 weeks per period
Population: Intention-to-treat (ITT) population with no imputation of missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Center | Weekly Standardized Dialysis Adequacy | 2.8 Weekly Standardized Kt/V | Standard Deviation 0.3 |
| In-Home | Weekly Standardized Dialysis Adequacy | 2.8 Weekly Standardized Kt/V | Standard Deviation 0.3 |
Secondary
Ultrafiltration Rate Success
The Ultrafiltration (UF) rate was calculated using the following method: UF rate = (Fluid Removal Goal + Rinse Back Volume) / Treatment Duration. Where: Fluid Removal Goal = (Today's Weight - Prescribed Estimated Dry Weight) And: Rinse Back Volume = The volume of saline, 300mL, returned to the patient at the end of treatment. Each dialysis treatment was flagged as a success with respect to UF if the actual UF rate was within 10% of the prescribed UF rate. The mean (i.e., success proportion) and standard deviation were computed by treatment period across all subjects, where the denominator for the mean calculations was the total number of treatments in each treatment period for which the subjects contributed non-missing UF data.
Time frame: 8 weeks per period
Population: Intention-to-treat (ITT) population with no imputation of missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-Center | Ultrafiltration Rate Success | 94 Percentage of Dialysis Treatments |
| In-Home | Ultrafiltration Rate Success | 94 Percentage of Dialysis Treatments |