Renal Replacement TherapyBEAM-1NCT01023893
Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)
An observational study of Renal Replacement Therapy, run by ProMetrics, Inc..
Trial summary
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will be evaluated dynamically for their blood viscosity status at the beginning and end of the dialysis treatment, and followed prospectively to assess… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Nov 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dialysis clinic
Who may be able to join
- Age > 18 years old
- On hemodialysis > 3 months
- On ESA treatment > 3 months
- Mean Hgb 11 g/dL - 12 g/dL (based on at least 3 Hgb results during the previous 8 weeks)
- Latest Hgb 10.5 g/dL - 12.5 g/dL (measured within 1 week of study)
Who cannot join
- Inability or unwillingness to provide informed consent
- Large variability in interdialytic weight gain (>2 kg difference between low and high weight gain over last month)
- More than 1 missed dialysis treatments in past month
- Recent bleeding
- Blood transfusion within 1 month
- Hematologic disease other than anemia
- Active inflammatory disease
- Active infection
About this study
Official title: Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will be evaluated dynamically for their blood viscosity status at the beginning and end of the dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment visit. Blood will be analyzed at a designated laboratory facility for viscosity over a comprehensive range of shear rates and tested for intradialytic surges in blood viscosity. Subjects will be followed for 48 weeks.
- Conditions
- Renal Replacement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| End-stage renal disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality
Measured: One year
Secondary outcomes (2)
All-cause mortality
Measured: One year
Vascular access thrombosis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement TherapyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProMetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023893
- Sponsor's protocol ID
- PRO-0062-201
- Acronym
- BEAM-1
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vaisman S, Kensey K, Cho YI. Effect of hemodialysis on whole blood viscosity. Int J Artif Organs. 2009 Jun;32(6):329-35. doi: 10.1177/039139880903200603.
PubMed 19670184Lowe GD, Lee AJ, Rumley A, Price JF, Fowkes FG. Blood viscosity and risk of cardiovascular events: the Edinburgh Artery Study. Br J Haematol. 1997 Jan;96(1):168-73. doi: 10.1046/j.1365-2141.1997.8532481.x.
PubMed 9012704
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality
- ClinicalTrials.gov ID
- NCT01023893
- Acronym / sponsor ID
- BEAM-1 / PRO-0062-201
- Conditions
- Renal Replacement Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ProMetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- First posted
- 2 Dec 2009 (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.
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will be evaluated dynamically for their blood viscosity status at the beginning and end of the dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment visit. Blood will be analyzed at a designated laboratory facility for viscosity over a comprehensive range of shear rates and tested for intradialytic surges in blood viscosity. Subjects will be followed for 48 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-stage renal disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dialysis clinic
Key inclusion criteria (5 listed)
- Age > 18 years old
- On hemodialysis > 3 months
- On ESA treatment > 3 months
- Mean Hgb 11 g/dL - 12 g/dL (based on at least 3 Hgb results during the previous 8 weeks)
- Latest Hgb 10.5 g/dL - 12.5 g/dL (measured within 1 week of study)
Key exclusion criteria (8 listed)
- Inability or unwillingness to provide informed consent
- Large variability in interdialytic weight gain (>2 kg difference between low and high weight gain over last month)
- More than 1 missed dialysis treatments in past month
- Recent bleeding
- Blood transfusion within 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular mortality
Time frame: One year
2 secondary outcomes
All-cause mortality
Time frame: One year
Vascular access thrombosis
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
- Background: PubMed 19670184Vaisman S, Kensey K, Cho YI. Effect of hemodialysis on whole blood viscosity. Int J Artif Organs. 2009 Jun;32(6):329-35. doi: 10.1177/039139880903200603.
- Background: PubMed 9012704Lowe GD, Lee AJ, Rumley A, Price JF, Fowkes FG. Blood viscosity and risk of cardiovascular events: the Edinburgh Artery Study. Br J Haematol. 1997 Jan;96(1):168-73. doi: 10.1046/j.1365-2141.1997.8532481.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Replacement Therapy, run by ProMetrics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01023893, which also lists 2 linked publications.
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 2 Dec 2009.