End Stage Renal DiseasePhase 2/3BME-1NCT01416896
New Needle for Two-Needle Hemodialysis
A Phase 2/3 study testing Hemodialysis using the standard venous needle and Hemodialysis using a new venous needle, the "BME needle" in people with End Stage Renal Disease, run by Biomedical Enterprises Inc at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Hemodialysis using the standard venous needle and Hemodialysis using a new venous needle, the "BME needle"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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,
Exclusion Criteria:patients with fever, infection, inflammation or malignancy will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DaVita K Street Dialysis Center
Washington D.C., District of Columbia, 20037
Pedro A Jose, MD, PhD, 202-476-5715, pjose@cnmc.org
Pedro A Jose, Md, PhD
About this study
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Hemodialysis using the standard venous needle, Hemodialysis using a new venous needle, the "BME needle"
- Keywords
- End stage Renal Disease, Hemodialysis, Oxidative Stress, Inflammation
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis using the standard venous needleProcedure or surgery
Also called hemodialysis using the standard venous dialysis needle
Hemodialysis using the standard venous dialysis needle
Hemodialysis using a new venous needle, the "BME needle"Procedure or surgery
Also called The "BME needle" is a newly designed venous dialysis needle.
Hemodialysis using a new venous dialysis needle or the "BME needle"
Hemodialysis using a new venous needle, the "BME needle"Procedure or surgery
One hemodialysis using a new venous needle, the "BME needle"
Hemodialysis using the standard venous needleProcedure or surgery
One hemodialysis using the standard venous needle
| Study group | Role | What they receive |
|---|---|---|
| New venous needle, the "BME needle" | Experimental | Hemodialysis using the new venous needle, the "BME needle". Receives: Procedure: Hemodialysis using a new venous needle, the "BME needle" |
| Standard venous needle, the "standard needle" | Active comparator | One hemodialysis using the standard venous needle, the "standard needle" (device). Receives: Procedure: Hemodialysis using the standard venous needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
The net change in the levels of intracellular IL-6, IL-6 soluble receptor, IL-6 gp130, superoxide, H2O2 and IL-1 during dialysis (difference between pre and post dialysis) using the new venous needle will be compared with the change using the current venous needle.
Measured: 4 hours of hemodialysis
Secondary outcomes (1)
Net change in oxidative stress and proinflammatory cytokines in plasma
The net change in the plasma levels of IL-1, IL-6, MDA and AOPP during dialysis (difference between pre and post dialysis) using the new venous needle will be compared with the net change that occurs in patients using the current venous needle
Measured: 4 hours hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedical Enterprises Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alfredo R Zarate, MD, Principal investigator, Biomedical Enterprises IncPedro A Jose, MD, PhD, Principal investigator, Children National Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416896
- Sponsor's protocol ID
- BME-1
- Other IDs
- R44DK059062
- Acronym
- BME-1
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Needle for Two-Needle Hemodialysis
- ClinicalTrials.gov ID
- NCT01416896
- Acronym / sponsor ID
- BME-1 / BME-1
- Conditions
- End Stage Renal Disease
- Keywords
- End stage Renal Disease, Hemodialysis, Oxidative Stress, Inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Biomedical Enterprises IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New venous needle, the "BME needle" | Experimental | Procedure: Hemodialysis using a new venous needle, the "BME needle"Hemodialysis using the new venous needle, the "BME needle". |
| Standard venous needle, the "standard needle" | Active comparator | Procedure: Hemodialysis using the standard venous needleOne hemodialysis using the standard venous needle, the "standard needle" (device). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis using the standard venous needleAlso: hemodialysis using the standard venous dialysis needleHemodialysis using the standard venous dialysis needle | Procedure or surgery | Standard venous needle, the "standard needle" |
| Hemodialysis using a new venous needle, the "BME needle"Also: The "BME needle" is a newly designed venous dialysis needle.Hemodialysis using a new venous dialysis needle or the "BME needle" | Procedure or surgery | New venous needle, the "BME needle" |
| Hemodialysis using a new venous needle, the "BME needle"One hemodialysis using a new venous needle, the "BME needle" | Procedure or surgery | New venous needle, the "BME needle" |
| Hemodialysis using the standard venous needleOne hemodialysis using the standard venous needle | Procedure or surgery | Standard venous needle, the "standard needle" |
Primary outcome
Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
Time frame: 4 hours of hemodialysis
The net change in the levels of intracellular IL-6, IL-6 soluble receptor, IL-6 gp130, superoxide, H2O2 and IL-1 during dialysis (difference between pre and post dialysis) using the new venous needle will be compared with the change using the current venous needle.
1 secondary outcome
Net change in oxidative stress and proinflammatory cytokines in plasma
Time frame: 4 hours hemodialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo R Zarate, MD principal investigator
Biomedical Enterprises Inc
Pedro A Jose, MD, PhD principal investigator
Children National Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hemodialysis using the standard venous needle and Hemodialysis using a new venous needle, the "BME needle" in people with End Stage Renal Disease, run by Biomedical Enterprises Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro A Jose, MD, PhD (202-476-5715, pjose@cnmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels (time frame: 4 hours of hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011; AzTrials last refreshed its copy on 29 Oct 2026.