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New Needle for Two-Needle Hemodialysis (BME-1 Trial)

Phase 2 & 3
Waitlist Available
Led By Alfredo R Zarate, MD
Research Sponsored by Biomedical Enterprises Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion Criteria:(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or AV fistula as vascular access
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours hemodialysis
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new dialysis needle that returns cleaned blood more smoothly. It aims to improve treatment efficiency and reduce complications by making blood flow gentler for patients.

Eligible Conditions
  • Kidney Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours hemodialysis
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours hemodialysis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
Secondary study objectives
Net change in oxidative stress and proinflammatory cytokines in plasma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: New venous needle, the "BME needle"Experimental Treatment1 Intervention
Hemodialysis using the new venous needle, the "BME needle".
Group II: Standard venous needle, the "standard needle"Active Control1 Intervention
One hemodialysis using the standard venous needle, the "standard needle" (device).

Find a Location

Who is running the clinical trial?

Biomedical Enterprises IncLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,383 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Alfredo R Zarate, MDPrincipal InvestigatorBiomedical Enterprises Inc
Pedro A Jose, MD, PhDPrincipal InvestigatorChildren National Medical Center
1 Previous Clinical Trials
45 Total Patients Enrolled
~5 spots leftby Jan 2026
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