Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Device: HemoCare™ Hemodialysis System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective multi-center, open-label, single-arm, cross-over study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The HemoCare™ Hemodialysis System<br>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. | Device: HemoCare™ Hemodialysis System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods | 31 weeks | 
| Primary Performance Endpoint | Weekly stdKt/Vurea as measured every two weeks during each Evaluable Period. | 31 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 31 weeks | 
| The incidences of decreased and increased post-dialysis serum phosphorus levels | The incidence of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level < 2.2 mg/dL , the incidence 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. | 31 weeks | 
| The incidences of decreased and increased post-dialysis serum potassium during each Evaluable Period. | The incidence of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of < 3.5 meq/L , and the incidence 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. | 31 weeks | 
| A descriptive summary of ultrafiltration and target weight during each Evaluable Period. | A descriptive summary of ultrafiltration and target pre-dialysis and post-dialysis weight during each Evaluable Period. | 31 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HemoCare™ Hemodialysis System, Hemodialysis