End-Stage Renal DiseasePhase 3NCT00714662
High Flux Hemodialysis Thrice Versus Once
A Phase 3 study testing high flux hemodialyzer (FX-60, FX-80 or FX-100) in people with End-Stage Renal Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy. 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?
- high flux hemodialyzer (FX-60, FX-80 or FX-100)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 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
Who may be able to join
- ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
- Age: 18~80 years old.
- Blood flow during dialysis ≧ 250ml/min
Who cannot join
- Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
- Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
- Bacteremia, myocardial infarction or stroke in previous 3 months.
- Known diagnosis with dialysis related amyloidosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yung-Ming Chen, M.D., 00886-2-23123456 ext. 5993, chenym@ntuh.gov.tw
Yung-Ming Chen, M.D.
About this study
Official title: Effects of Different Frequencies of High-Flux Membranes on Blood Pressure, Fluid Balance, and Indices of Nutrition, Inflammation, and Dialysis Adequacy in Chronic Hemodialysis Patients - Comparisons Between Thrice vs Once Weekly
To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.
Read the detailed description
This study will be conducted in the HD center at NTUH. Patients undergoing chronic HD for at least 6 months will be evaluated for eligibility. Patients with previous adverse reactions to FX series dialyzer will not be included in this study. Detailed demographic physical characteristics of the participants will be recorded, including age, gender, underlying diseases, blood pressure, intradialytic complications, as well as indices of nutrition, inflammation, and dialysis adequacy. Eligible patients will first undergo a 4-week run-in HD with conventional-flux dialyzer twice weekly plus high-flux dialyzer once weekly (i.e., basic formula), followed by random allocation into two separate groups. Patients in group A will continue HD with the basic formula, while those in group B will receive HD using high-flux membranes thrice weekly. Three months later, all participants will be put back on HD with basic formula for 1 month (wash-out period). Group A patients will then be switched to receive HD with high-flux membranes thrice weekly, and group B patients will be changed to undergo HD with basic formula for another 3 months. Laboratory tests will include monthly biochemistry and hemogram, plus blood and urine specimens taken on 4 occasions before and during the study (baseline, end of the first 3 months, end of wash-out, and end of the second 3 months) to investigate selective markers and indices for nutrition, inflammation, and dialysis adequacy.
- Conditions
- End-Stage Renal Disease
- Being tested
- high flux hemodialyzer (FX-60, FX-80 or FX-100)
- Keywords
- high flux 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.
high flux hemodialyzer (FX-60, FX-80 or FX-100)Device
Also called FX-60, FX-80 or FX-100
three sessions per week
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009 (estimated)
- Study completionMar 2009 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mrs. Hsiu-Chin Lee Kidney Research Fund
- Investigators
- Yung-Ming Chen, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714662
- Sponsor's protocol ID
- 200803055R
- Status last verified
- Jul 2008
- First submitted
- 9 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Frequencies of High-Flux Membranes on Blood Pressure, Fluid Balance, and Indices of Nutrition, Inflammation, and Dialysis Adequacy in Chronic Hemodialysis Patients - Comparisons Between Thrice vs Once Weekly
- ClinicalTrials.gov ID
- NCT00714662
- Acronym / sponsor ID
- 200803055R
- Conditions
- End-Stage Renal Disease
- Keywords
- high flux hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Mrs. Hsiu-Chin Lee Kidney Research Fund
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 14 Jul 2008 (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.
To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.
Detailed description
This study will be conducted in the HD center at NTUH. Patients undergoing chronic HD for at least 6 months will be evaluated for eligibility. Patients with previous adverse reactions to FX series dialyzer will not be included in this study. Detailed demographic physical characteristics of the participants will be recorded, including age, gender, underlying diseases, blood pressure, intradialytic complications, as well as indices of nutrition, inflammation, and dialysis adequacy. Eligible patients will first undergo a 4-week run-in HD with conventional-flux dialyzer twice weekly plus high-flux dialyzer once weekly (i.e., basic formula), followed by random allocation into two separate groups. Patients in group A will continue HD with the basic formula, while those in group B will receive HD using high-flux membranes thrice weekly. Three months later, all participants will be put back on HD with basic formula for 1 month (wash-out period). Group A patients will then be switched to receive HD with high-flux membranes thrice weekly, and group B patients will be changed to undergo HD with basic formula for another 3 months. Laboratory tests will include monthly biochemistry and hemogram, plus blood and urine specimens taken on 4 occasions before and during the study (baseline, end of the first 3 months, end of wash-out, and end of the second 3 months) to investigate selective markers and indices for nutrition, inflammation, and dialysis adequacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
- Age: 18~80 years old.
- Blood flow during dialysis ≧ 250ml/min
Key exclusion criteria (4 listed)
- Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
- Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
- Bacteremia, myocardial infarction or stroke in previous 3 months.
- Known diagnosis with dialysis related amyloidosis
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 |
|---|---|---|
| high flux hemodialyzer (FX-60, FX-80 or FX-100)Also: FX-60, FX-80 or FX-100three sessions per week | Device | – |
Primary outcome
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2008.
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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.
Yung-Ming Chen, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing high flux hemodialyzer (FX-60, FX-80 or FX-100) in people with End-Stage Renal Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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 Jul 2008. 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 Taiwan. 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 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 Yung-Ming Chen, M.D. (00886-2-23123456 ext. 5993, chenym@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy (time frame: 6 months). 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 Jul 2008.