End Stage Renal DiseasePhase 4NCT01103167
Body Composition Monitor in Hemodialysis Patients
A Phase 4 study of End Stage Renal Disease, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed. The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 4
- 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
Who may be able to join
- 6-month or more stable hemodialysis patients
- 18 years or more
- less than 5% of changes of dry weight for last 3 months
Who cannot join
- pregnancy
- active malignancy
- cardiac pacemaker or defibrillator
- history of extremity amputation
- active infectious disease within 3 months
- admission history for complication related to hemodialysis within 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sejoong Kim
Incheon, 405-760
Sejoong Kim, MD, PhD, 82-32-460-8305, imsejoong@hanmail.net
Kwon Wook Joo, MD, PhD, 82-2-2072-1964, junephro@paran.com
About this study
Official title: The Association Between Body Composition and Biomarkers in Hemodialysis Patients
Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.
The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.
Read the detailed description
The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.
During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.
- Conditions
- End Stage Renal Disease
- Being tested
- control of ultrafiltration
- Keywords
- body composition, blood pressure, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control of ultrafiltrationBehavioural
During the interventional period, dry weight of patients will be adjusted according to the results of body composition.
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
Measured: up to 16 weeks
Secondary outcomes (1)
biomarkers
C-reactive protein, interleukin-6, MMP-1, leptin, resistin, adiponectin, VEGF
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sejoong Kim, MD, PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103167
- Sponsor's protocol ID
- korea_bcm_hd
- Status last verified
- Apr 2010
- First submitted
- 9 Apr 2010
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Body Composition and Biomarkers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01103167
- Acronym / sponsor ID
- korea_bcm_hd
- Conditions
- End Stage Renal Disease
- Keywords
- body composition, blood pressure, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 14 Apr 2010 (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.
Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.
The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.
Detailed description
The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.
During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 6-month or more stable hemodialysis patients
- 18 years or more
- less than 5% of changes of dry weight for last 3 months
Key exclusion criteria (6 listed)
- pregnancy
- active malignancy
- cardiac pacemaker or defibrillator
- history of extremity amputation
- active infectious disease within 3 months
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 |
|---|---|---|
| control of ultrafiltrationDuring the interventional period, dry weight of patients will be adjusted according to the results of body composition. | Behavioural | – |
Primary outcome
blood pressure
Time frame: up to 16 weeks
Systolic blood pressure, number of anti-hypertensive agents hypotensive episode
1 secondary outcome
biomarkers
Time frame: up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2010.
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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.
Sejoong Kim, MD, PhD principal investigator
Gachon University Gil 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 4 study of End Stage Renal Disease, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 3 inclusion and 6 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 14 Apr 2010. 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 South Korea. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Sejoong Kim, MD, PhD (82-32-460-8305, imsejoong@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: up to 16 weeks). 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 14 Apr 2010.