search
Back to results

An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System

Primary Purpose

End Stage Renal Disease

Status
Active
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, HemoCare™, Hemodialysis

Eligibility Criteria

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

Inclusion Criteria:

  • Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator.
  • Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System.
  • Have a trained study care partner able to support subject for all at-home study treatments.
  • Subject and care partner can read and understand English and provide written informed consent.
  • Have a stable functioning vascular access as judged by the treating physician.

Exclusion Criteria:

  • Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
  • Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study.
  • 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.
  • Are participating or planning to participate in any other interventional studies except DKPL-00057-001.

Sites / Locations

  • University of Mississippi Medical Center
  • DCI North Brunswick
  • The Rogosin Institute
  • Dialysis Clinic, Inc.
  • Dialysis Clinic, Inc.
  • Wellbound South Austin
  • Wellbound North Austin

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

Safety Measures
Proportion of subjects having at least one of the following: anticipated Adverse Event, anticipated Serious Adverse Event, unanticipated Adverse Event, unanticipated Serious Adverse Event, device-related Adverse Event, device-related Serious Adverse Event

Secondary Outcome Measures

Full Information

First Posted
December 5, 2019
Last Updated
June 22, 2023
Sponsor
Deka Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT04198012
Brief Title
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
Official Title
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deka Research and Development

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 study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the 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, HemoCare™, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label rollover study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (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
Safety Measures
Description
Proportion of subjects having at least one of the following: anticipated Adverse Event, anticipated Serious Adverse Event, unanticipated Adverse Event, unanticipated Serious Adverse Event, device-related Adverse Event, device-related Serious Adverse Event
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator. Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System. Have a trained study care partner able to support subject for all at-home study treatments. Subject and care partner can read and understand English and provide written informed consent. Have a stable functioning vascular access as judged by the treating physician. Exclusion Criteria: Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study. Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study. 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. Are participating or planning to participate in any other interventional studies except DKPL-00057-001.
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
DCI North Brunswick
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.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
background
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
background
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
background
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
background
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

Learn more about this trial

An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System

We'll reach out to this number within 24 hrs