- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087213
Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD
February 7, 2023 updated by: Deka Research and Development
Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39213
- University of Mississippi Medical Center
-
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New Jersey
-
North Brunswick, New Jersey, United States, 08902
- Dialysis Clinic, Inc - NJ
-
-
New York
-
New York, New York, United States, 11021
- The Rogosin Institute
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Tennessee
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Knoxville, Tennessee, United States, 37924
- Dialysis Clinic Inc. - Knoxville
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Nashville, Tennessee, United States, 37203
- Dialysis Clinic, Inc.
-
-
Texas
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Austin, Texas, United States, 78744
- Wellbound South Austin
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Austin, Texas, United States, 78758
- Wellbound North Austin
-
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: The HemoCare™ Hemodialysis System
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Endpoint
Time Frame: 31 weeks
|
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
|
31 weeks
|
Primary Performance Endpoint
Time Frame: 31 weeks
|
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)
Time Frame: 31 weeks
|
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
Time Frame: 31 weeks
|
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.
Time Frame: 31 weeks
|
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.
Time Frame: 31 weeks
|
A descriptive summary of ultrafiltration and target pre-dialysis and post-dialysis weight during each Evaluable Period.
|
31 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The reliability and the ability of the HemoCareTM Hemodialysis System
Time Frame: 31 weeks
|
To assess the reliability and ability of the HemoCareTM Hemodialysis System to deliver the prescribed treatments.
Treatments will be classified as either complete (receiving at least 90% of planned treatment time), incomplete (receiving less than this), or missed altogether by the site staff.
Planned treatment will be defined as the treatment time selected and confirmed by the user at the start of each treatment.
|
31 weeks
|
Descriptive summary statistics of successful and unsuccessful completion of subjects completing HemoCareTM training and entering Unassisted Home Evaluation Period
Time Frame: 31 weeks
|
Descriptive summary statistics of the proportion of subjects and care partners who successfully complete training with HemoCareTM and enter the Unassisted Home Evaluation Period of the study.
|
31 weeks
|
Renal Treatment Satisfaction Questionnaire (RTSQ)
Time Frame: 31 weeks
|
RTSQ is an established Questionnaire to assess the treatment of the subject's kidney condition and their experience over the weeks prior to week 6.
|
31 weeks
|
Patient Recovery Time Questionnaire
Time Frame: 31 weeks
|
PRTQ is an established Questionnaire to determine how many minutes the subject takes to recover from a dialysis session.
|
31 weeks
|
Zarit Burden Interview - 12 item version (ZBI-12)
Time Frame: 31 weeks
|
ZBI-12 is an established Questionnaire to determine care partner scores measuring the act of taking care of another person
|
31 weeks
|
Descriptive summary of the time(s) to resolve HemoCareTM device alarms
Time Frame: 31 weeks
|
During the dialysis session, a summary of the time(s) to resolve the alarms will be measured.
|
31 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Eloot S, Van Biesen W, Dhondt A, Van de Wynkele H, Glorieux G, Verdonck P, Vanholder R. Impact of hemodialysis duration on the removal of uremic retention solutes. Kidney Int. 2008 Mar;73(6):765-70. doi: 10.1038/sj.ki.5002750. Epub 2007 Dec 26.
- Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, Mahallati H, Hemmelgarn BR, Manns BJ. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007 Sep 19;298(11):1291-9. doi: 10.1001/jama.298.11.1291.
- Rocco MV, Lockridge RS Jr, Beck GJ, Eggers PW, Gassman JJ, Greene T, Larive B, Chan CT, Chertow GM, Copland M, Hoy CD, Lindsay RM, Levin NW, Ornt DB, Pierratos A, Pipkin MF, Rajagopalan S, Stokes JB, Unruh ML, Star RA, Kliger AS; Frequent Hemodialysis Network (FHN) Trial Group; Kliger A, Eggers P, Briggs J, Hostetter T, Narva A, Star R, Augustine B, Mohr P, Beck G, Fu Z, Gassman J, Greene T, Daugirdas J, Hunsicker L, Larive B, Li M, Mackrell J, Wiggins K, Sherer S, Weiss B, Rajagopalan S, Sanz J, Dellagrottaglie S, Kariisa M, Tran T, West J, Unruh M, Keene R, Schlarb J, Chan C, McGrath-Chong M, Frome R, Higgins H, Ke S, Mandaci O, Owens C, Snell C, Eknoyan G, Appel L, Cheung A, Derse A, Kramer C, Geller N, Grimm R, Henderson L, Prichard S, Roecker E, Rocco M, Miller B, Riley J, Schuessler R, Lockridge R, Pipkin M, Peterson C, Hoy C, Fensterer A, Steigerwald D, Stokes J, Somers D, Hilkin A, Lilli K, Wallace W, Franzwa B, Waterman E, Chan C, McGrath-Chong M, Copland M, Levin A, Sioson L, Cabezon E, Kwan S, Roger D, Lindsay R, Suri R, Champagne J, Bullas R, Garg A, Mazzorato A, Spanner E, Rocco M, Burkart J, Moossavi S, Mauck V, Kaufman T, Pierratos A, Chan W, Regozo K, Kwok S. The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011 Nov;80(10):1080-91. doi: 10.1038/ki.2011.213. Epub 2011 Jul 20.
- Pauly RP, Gill JS, Rose CL, Asad RA, Chery A, Pierratos A, Chan CT. Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients. Nephrol Dial Transplant. 2009 Sep;24(9):2915-9. doi: 10.1093/ndt/gfp295. Epub 2009 Jul 7.
- Bernardo AA, Marbury TC, McFarlane PA, Pauly RP, Amdahl M, Demers J, Hutchcraft AM, Leypoldt JK, Minkus M, Muller M, Stallard R, Culleton BF. Clinical safety and performance of VIVIA: a novel home hemodialysis system. Nephrol Dial Transplant. 2017 Apr 1;32(4):685-692. doi: 10.1093/ndt/gfw044.
- U.S. Renal Data System. USRDS 2017 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2017
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 5, 2019
Primary Completion (ACTUAL)
January 11, 2023
Study Completion (ACTUAL)
January 11, 2023
Study Registration Dates
First Submitted
August 30, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (ACTUAL)
September 12, 2019
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DKPL-00057-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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