Clinical Evaluation Hemodialysis System for Home Nocturnal Hemodialysis

About this Study

This study is designed to compare HemoCare dialysis system to current dialysis treatment.

Sponsor Protocol ID:DKPL-00057-001
IRB Number:2021V0444
Actively Enrolling
Interventional
Observational/Not Applicable
October 22, 2021
Eligibility Criteria
18 years old
Both Male and Female
No
No
No

Inclusion Criteria1. Have been diagnosed with ESRD and are ≥ 18 years of age.

2.  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.

3.  Have been dialyzing in a supervised medical facility or at home for ≥ 3 times per week.

4.  Understand English and can provide written informed consent (both the subject and care partner).

5.  Have a stable functioning vascular access as judged by the treating physician.

Exclusion Criteria1. Are pre-scheduled for a living donor transplant within the next 6 months.

2. Have a contraindication to heparin.

3. Are currently participating in another interventional study.

4. 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.

5. Have an allergy to polysulfone dialyzer.

6. 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.

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Kidney/Renal Conditions
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Delia Owens
Phone Number: 601-815-9231
Email: dyowens@umc.edu
Principal Investigator:Tariq Shafi
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