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Hemodialysis System

HemoCare™ Hemodialysis System for Kidney Failure

N/A
Waitlist Available
Research Sponsored by Deka Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 weeks
Awards & highlights

Study Summary

This trial will study the safety of using a HemoCare Hemodialysis System at night.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Performance Endpoint
Primary Safety Endpoint
Secondary outcome measures
A descriptive summary of ultrafiltration and target weight during each Evaluable Period.
The incidences of decreased and increased post-dialysis serum phosphorus levels
The incidences of decreased and increased post-dialysis serum potassium during each Evaluable Period.
+1 more
Other outcome measures
Descriptive summary of the time(s) to resolve HemoCareTM device alarms
Descriptive summary statistics of successful and unsuccessful completion of subjects completing HemoCareTM training and entering Unassisted Home Evaluation Period
Patient Recovery Time Questionnaire
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: The HemoCare™ Hemodialysis SystemExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HemoCare™ Hemodialysis System
2019
N/A
~40

Find a Location

Who is running the clinical trial?

CVS Kidney Care LLC.UNKNOWN
1 Previous Clinical Trials
26 Total Patients Enrolled
Deka Research and DevelopmentLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities to join this experimental program?

"According to the information on clinicaltrials.gov, this particular medical trial is not presently accepting participants. Originally shared on September 5th 2019, it was last modified on July 14th 2022 and has yet to resume recruiting patients. However, 180 other trials are actively enrolling individuals at present."

Answered by AI

What aims are being pursued with this research project?

"This 31-week clinical trial will evaluate the primary safety endpoint as its main outcome. Secondary outcomes, including a descriptive summary of ultrafiltration and target pre-dialysis/post-dialysis weight during each evaluable period, total number of anticipated/unanticipated adverse events (AEs) or serious AEs (SAEs), and incidences of decreased/increased post-dialysis serum potassium levels during each evaluable period, will be compared between different periods with exact McNemar's tests."

Answered by AI

How many research sites are engaged in this trial?

"This research trial is currently in progress at 8 medical facilities, including Dialysis Clinic Inc - NJ located in North Brunswick, University of Virginia situated in Charlottesville and The Rogosin Institute found within New york City. There are 5 other clinical sites participating as well."

Answered by AI
Recent research and studies
JamaJournal
Effect of Frequent Nocturnal Hemodialysis Vs Conventional Hemodialysis on Left Ventricular Mass and Quality of Life
Culleton, Bruce F., Michael Walsh, Scott W. Klarenbach, Garth Mortis, Narine Scott-Douglas, Robert R. Quinn, Marcello Tonelli, et al.. 2007. “Effect of Frequent Nocturnal Hemodialysis Vs Conventional Hemodialysis on Left Ventricular Mass and Quality of Life”. Jama. American Medical Association (AMA). doi:10.1001/jama.298.11.1291.
Nephrology Dialysis TransplantationJournal
Survival Among Nocturnal Home Haemodialysis Patients Compared to Kidney Transplant Recipients
Pauly, R. P., J. S. Gill, C. L. Rose, R. A. Asad, A. Chery, A. Pierratos, and C. T. Chan. 2009. “Survival Among Nocturnal Home Haemodialysis Patients Compared to Kidney Transplant Recipients”. Nephrology Dialysis Transplantation. Oxford University Press (OUP). doi:10.1093/ndt/gfp295.
Kidney InternationalJournal
Impact of Hemodialysis Duration on the Removal of Uremic Retention Solutes
Eloot, S., W. Van Biesen, A. Dhondt, H. Van de Wynkele, G. Glorieux, P. Verdonck, and R. Vanholder. 2008. “Impact of Hemodialysis Duration on the Removal of Uremic Retention Solutes”. Kidney International. Elsevier BV. doi:10.1038/sj.ki.5002750.
Nephrology Dialysis TransplantationJournal
Clinical Safety and Performance of VIVIA: A Novel Home Hemodialysis System
Bernardo, Angelito A., Thomas C. Marbury, Phil A. McFarlane, Robert P. Pauly, Michael Amdahl, Jason Demers, Audrey M. Hutchcraft, et al.. 2016. “Clinical Safety and Performance of VIVIA: A Novel Home Hemodialysis System”. Nephrology Dialysis Transplantation. Oxford University Press (OUP). doi:10.1093/ndt/gfw044.
~6 spots leftby Apr 2025
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