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Trial record 1 of 1 for:    NCT04087213
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Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD

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ClinicalTrials.gov Identifier: NCT04087213
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
CVS Kidney Care LLC.
Information provided by (Responsible Party):
Deka Research and Development

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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Device: HemoCare™ Hemodialysis System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective multi-center, open-label, single-arm, cross-over study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : May 13, 2022
Estimated Study Completion Date : May 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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.
Device: 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.




Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 31 weeks ]
    Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods

  2. Primary Performance Endpoint [ Time Frame: 31 weeks ]
    Weekly stdKt/Vurea as measured every two weeks during each Evaluable Period.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087213


Contacts
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Contact: Sarah Sereno 603-669-5139 ext 6170 ssereno@dekaresearch.com
Contact: Heather Maurer 603-669-5139 ext 6131 hmaurer@dekaresearch.com

Locations
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United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 11021
Contact: Frank Liu, M.D.         
Principal Investigator: Frank Liu, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Emaad Abdel-Rahman, MD         
Principal Investigator: Emaad Abdel-Rahman, MD         
Sponsors and Collaborators
Deka Research and Development
CVS Kidney Care LLC.
Publications:
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
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.

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Responsible Party: Deka Research and Development
ClinicalTrials.gov Identifier: NCT04087213    
Other Study ID Numbers: DKPL-00057-001
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Deka Research and Development:
HemoCare™ Hemodialysis System
Hemodialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency