End-Stage Renal Disease
Conditions
Keywords
HemoCare™ Hemodialysis System, Hemodialysis
Brief summary
This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.
Detailed description
The HemoCare™ Hemodialysis System has been evaluated in previous clinical trials and is designed to perform hemodialysis (HD) in a clinic setting, in a self-care setting, or in a home environment for conventional HD, short daily HD or extended-duration HD therapy during the daytime or at night dependent on the users' lifestyle or work schedule. This multi-center, open-label, single-arm cross-over study is designed specifically to gather and evaluate safety data for the use of the HemoCare™ Hemodialysis System (including labeling and training tools) during home nocturnal (during sleeping hours based on the patient schedule) use. Nocturnal HD therapy was chosen as a treatment in this study because of the clinical and humanistic benefits associated with it. In addition, its risk profile, especially when performed in a home setting, may be greater than either existing conventional or short daily HD therapies. In this regard, establishing an acceptable safety profile for home nocturnal HD therapy should be sufficient evidence to support conventional and short daily HD home therapies with HemoCare™ Hemodialysis System.
Interventions
The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.
Sponsors
CVS Kidney Care LLC.
Deka Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective multi-center, open-label, single-arm, cross-over study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with ESRD and are ≥ 18 years of age. * Are in stable clinical condition as judged by the treating physician, and confirmed by medical history, physical exam, and laboratory testing for 30 days prior to enrollment. * Have been receiving HD for at least 30 days prior to study enrollment, are expected to survive for at least 12 months and in the opinion of the Investigator are stable to start in the trial. * Have been dialyzing in a supervised medical facility or at home for ≥ 3 times per week. * Are willing to comply with the study requirements for training and therapy with HemoCare™ Hemodialysis System for the entire study treatment period. * Understand English and can provide written informed consent (both the subject and care partner). * Are judged by the Investigator to be suitable for Home HD (the Investigator deems that with appropriate training, the subject and/or care partner will be able to successfully cannulate and/or manage the vascular access during the Unassisted Home Evaluable Period). * Have a stable functioning vascular access as judged by the treating physician. * Have a weekly stdKt/Vurea ≥ 2.0, an equivalent URR ≥ 0.65, rated Kt/Vurea ≥ 1.0 on one occasion within 30 days prior to enrollment.
Exclusion criteria
* Are pre-scheduled for a living donor transplant within the next 6 months. * Have a contraindication to heparin. * Are currently participating in another interventional study. * Have experienced an acute myocardial infarction with hospitalization, coronary artery bypass surgery, or acute coronary ischemia requiring angioplasty or stent insertion within 90 days of screening. * Have ongoing NYHA Class III or IV heart failure. * Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures. * Have ongoing sepsis or bacteremia and currently require IV antibiotics. * Have an allergy to polysulfone dialyzer. * Current self-reported pregnancy, actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study. * Subject with fluid overload due to intractable ascites secondary to liver cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 31 weeks | Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods |
| Primary Performance Endpoint | 31 weeks | Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | 31 weeks | Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs. |
| The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels | 31 weeks | The number of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level \< 2.2 mg/dL , the number of elevated serum phosphorous defined as a least 1 post-dialysis serum phosphorus level \> 5.5 mg/dL, will each be compared between Evaluable Periods with exact McNemar's tests. |
| The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period. | 31 weeks | The number of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of \< 3.5 meq/L , and the number of elevated serum potassium defined as at least 1 post-dialysis serum potassium level of \> 5.9 meq/L, will each be compared between Evaluable Periods with exact McNemar's tests. |
| Weight Change and Fluid Removed Comparison Between Evaluable Periods | 31 weeks | HemoCare Ultrafiltration Comparison by Evaluable Period was determined by the following: Discrepancy between Weight Change and Net UF removed = Weight change - Net UF Removed Weight change = Ending weight - Starting weight (measured by digital weight scale). Net Ultrafiltration Removed = total UF removed - prime & rinseback, reported by the HemoCare system. Note: One kilogram (kg) = one liter (L) of fluid |
Countries
United States
Participant flow
Pre-assignment details
A required introduction to the HemoCare hemodialysis system and successful training for cannulation/ vascular access care at the study site for a minimum of 1-week prior to first home treatment (In-Facility Introduction Period).
Participants by arm
| Arm | Count |
|---|---|
| Intent-To-Treat (ITT) Population The ITT population was defined as all subjects who used HemoCare Hemodialysis System at least once during the Assisted Evaluable Period. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Assisted Evaluable Period | Personal reasons | 3 |
| Assisted Evaluable Period | Withdrawal by Subject | 2 |
| In-Facility Introduction | Adverse Event | 1 |
| In-Facility Introduction | Withdrawal by Subject | 1 |
| Transition Period B | Renal Transplantation | 1 |
Baseline characteristics
| Characteristic | Intent-To-Treat (ITT) Population |
|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 23 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 28 |
| other Total, other adverse events | 31 / 34 | 24 / 28 |
| serious Total, serious adverse events | 5 / 34 | 2 / 28 |
Outcome results
Primary
Primary Performance Endpoint
Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0.
Time frame: 31 weeks
Population: Weekly stdKt/Vurea collected from the Intent-To-Treat (ITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assisted Evaluable Period | Primary Performance Endpoint | 1 Percentage of subjects with Kt/V ≥ 2.0 |
| Unassisted Home Evaluable Period | Primary Performance Endpoint | 1 Percentage of subjects with Kt/V ≥ 2.0 |
Primary
Primary Safety Endpoint
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Time frame: 31 weeks
Population: The ITT population was defined as all subjects who used HemoCare Hemodialysis System at least once during the Assisted Evaluable Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Assisted Evaluable Period | Primary Safety Endpoint | 16.1 Adverse Events per 100 Treatments |
| Unassisted Home Evaluable Period | Primary Safety Endpoint | 11.6 Adverse Events per 100 Treatments |
Secondary
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
The number of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level \< 2.2 mg/dL , the number of elevated serum phosphorous defined as a least 1 post-dialysis serum phosphorus level \> 5.5 mg/dL, will each be compared between Evaluable Periods with exact McNemar's tests.
Time frame: 31 weeks
Population: Intent-To-Treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Assisted Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels | Decreased serum phosphorous | 48 occurrence of event |
| Assisted Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels | Increased serum phosphorous | 0 occurrence of event |
| Unassisted Home Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels | Decreased serum phosphorous | 32 occurrence of event |
| Unassisted Home Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels | Increased serum phosphorous | 2 occurrence of event |
Secondary
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
The number of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of \< 3.5 meq/L , and the number of elevated serum potassium defined as at least 1 post-dialysis serum potassium level of \> 5.9 meq/L, will each be compared between Evaluable Periods with exact McNemar's tests.
Time frame: 31 weeks
Population: Intent-To-Treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Assisted Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period. | Decreased serum potassium | 43 events |
| Assisted Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period. | Elevated serum potassium | 0 events |
| Unassisted Home Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period. | Decreased serum potassium | 24 events |
| Unassisted Home Evaluable Period | The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period. | Elevated serum potassium | 1 events |
Secondary
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs.
Time frame: 31 weeks
Population: Adverse Events reported by the Intent-To-Treat (ITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Anticipated Non-Serious AE | 148 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Device-Related Non-Serious AE | 27 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Non-Serious AE | 49 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Device-Related Serious AE | 0 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Anticipated Serious AE | 5 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Device-Related Non-Serious AE | 0 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Serious AE | 2 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Device-Related Serious AE | 0 events |
| Assisted Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Total Adverse Events | 204 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Device-Related Serious AE | 0 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Total Adverse Events | 139 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Anticipated Non-Serious AE | 11 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Anticipated Serious AE | 2 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Non-Serious AE | 26 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Serious AE | 0 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Device-Related Non-Serious AE | 7 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Device-Related Serious AE | 0 events |
| Unassisted Home Evaluable Period | The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related) | Unanticipated Device-Related Non-Serious AE | 0 events |
Secondary
Weight Change and Fluid Removed Comparison Between Evaluable Periods
HemoCare Ultrafiltration Comparison by Evaluable Period was determined by the following: Discrepancy between Weight Change and Net UF removed = Weight change - Net UF Removed Weight change = Ending weight - Starting weight (measured by digital weight scale). Net Ultrafiltration Removed = total UF removed - prime & rinseback, reported by the HemoCare system. Note: One kilogram (kg) = one liter (L) of fluid
Time frame: 31 weeks
Population: Intent-To-Treat (ITT) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Evaluable Period | Weight Change and Fluid Removed Comparison Between Evaluable Periods | 0.1 L | Standard Deviation 3.5 |
| Unassisted Home Evaluable Period | Weight Change and Fluid Removed Comparison Between Evaluable Periods | 0.1 L | Standard Deviation 1.1 |