← Back to Search

New venous needle, the "BME needle" for Kidney Failure (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

BME-1 Trial Summary

Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. More importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. These will decrease medical complications, the high cost of care and death in dialysis patients. The current study will corroborate the finding of previous studies.

Eligible Conditions
  • Kidney Failure

BME-1 Trial Eligibility Criteria

Inclusion Criteria

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

BME-1 Trial 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

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

BME-1 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
2,360 Previous Clinical Trials
4,314,782 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Alfredo R Zarate, MDPrincipal InvestigatorBiomedical Enterprises Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby May 2025