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

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: End-Stage Renal Disease
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39213
      • University of Mississippi Medical Center
  • 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
  • Tennessee
    • Knoxville, Tennessee, United States, 37924
      • Dialysis Clinic Inc. - Knoxville
    • Nashville, Tennessee, United States, 37203
      • Dialysis Clinic, Inc.
  • Texas
    • Austin, Texas, United States, 78744
      • Wellbound South Austin
    • Austin, Texas, United States, 78758
      • Wellbound North Austin
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

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.

What is the study measuring?

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/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.	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 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.	31 weeks
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.	31 weeks
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	31 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The reliability and the ability of the HemoCareTM Hemodialysis System	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	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)	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	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)	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	During the dialysis session, a summary of the time(s) to resolve the alarms will be measured.	31 weeks

Collaborators and Investigators

• Sponsor: Deka Research and Development
• Collaborators: CVS Kidney Care LLC.

Publications and helpful links

General 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
• 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.
• 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.
• 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.

Study record dates

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 (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis; HemoCare™ Hemodialysis System
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• 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