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

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HemoCare™ Hemodialysis System
Sponsored by
Deka Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring HemoCare™ Hemodialysis System, Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Mississippi Medical Center
  • Dialysis Clinic, Inc - NJ
  • The Rogosin Institute
  • Dialysis Clinic Inc. - Knoxville
  • Dialysis Clinic, Inc.
  • Wellbound South Austin
  • Wellbound North Austin
  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The HemoCare™ Hemodialysis System

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 30, 2019
Last Updated
February 7, 2023
Sponsor
Deka Research and Development
Collaborators
CVS Kidney Care LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT04087213
Brief Title
Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD
Official Title
Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deka Research and Development
Collaborators
CVS Kidney Care LLC.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
HemoCare™ Hemodialysis System, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective multi-center, open-label, single-arm, cross-over study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The HemoCare™ Hemodialysis System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HemoCare™ Hemodialysis System
Intervention Description
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 Measure Information:
Title
Primary Safety Endpoint
Description
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Time Frame
31 weeks
Title
Primary Performance Endpoint
Description
Weekly stdKt/Vurea as measured every two weeks during each Evaluable Period.
Time Frame
31 weeks
Secondary Outcome Measure Information:
Title
The total number of AEs and SAEs (anticipated, unanticipated, and device related)
Description
Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs.
Time Frame
31 weeks
Title
The incidences of decreased and increased post-dialysis serum phosphorus levels
Description
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.
Time Frame
31 weeks
Title
The incidences of decreased and increased post-dialysis serum potassium during each Evaluable Period.
Description
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.
Time Frame
31 weeks
Title
A descriptive summary of ultrafiltration and target weight during each Evaluable Period.
Description
A descriptive summary of ultrafiltration and target pre-dialysis and post-dialysis weight during each Evaluable Period.
Time Frame
31 weeks
Other Pre-specified Outcome Measures:
Title
The reliability and the ability of the HemoCareTM Hemodialysis System
Description
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.
Time Frame
31 weeks
Title
Descriptive summary statistics of successful and unsuccessful completion of subjects completing HemoCareTM training and entering Unassisted Home Evaluation Period
Description
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.
Time Frame
31 weeks
Title
Renal Treatment Satisfaction Questionnaire (RTSQ)
Description
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.
Time Frame
31 weeks
Title
Patient Recovery Time Questionnaire
Description
PRTQ is an established Questionnaire to determine how many minutes the subject takes to recover from a dialysis session.
Time Frame
31 weeks
Title
Zarit Burden Interview - 12 item version (ZBI-12)
Description
ZBI-12 is an established Questionnaire to determine care partner scores measuring the act of taking care of another person
Time Frame
31 weeks
Title
Descriptive summary of the time(s) to resolve HemoCareTM device alarms
Description
During the dialysis session, a summary of the time(s) to resolve the alarms will be measured.
Time Frame
31 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Dialysis Clinic, Inc - NJ
City
North Brunswick
State/Province
New Jersey
ZIP/Postal Code
08902
Country
United States
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Dialysis Clinic Inc. - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37924
Country
United States
Facility Name
Dialysis Clinic, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Wellbound South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Facility Name
Wellbound North Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
PubMed Identifier
18160958
Citation
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.
Results Reference
background
PubMed Identifier
17878421
Citation
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.
Results Reference
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PubMed Identifier
21775973
Citation
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.
Results Reference
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PubMed Identifier
19584107
Citation
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.
Results Reference
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PubMed Identifier
27190336
Citation
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.
Results Reference
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Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD

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