N/A N=36 Treatment

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

End-Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT04087213 ↗

Enrolled (actual)

Serious AEs

11.3%

Results posted

Aug 2024

Primary outcome: Primary: Primary Safety Endpoint — 16.1; 11.6 Adverse Events per 100 Treatments

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HemoCare™ Hemodialysis System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Deka Research and Development
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Safety Endpoint	16.1; 11.6	—
PRIMARY Primary Performance Endpoint	1; 1	—
SECONDARY The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)	204; 139; 148; 11; 5; 2	—
SECONDARY The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels	48; 32; 0; 2	—
SECONDARY The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.	43; 24; 0; 1	—
SECONDARY Weight Change and Fluid Removed Comparison Between Evaluable Periods	0.1; 0.1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04087213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.