End-Stage Renal DiseasePhase 4NCT00411177
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis
A Phase 4 study testing post-dilution on-line hemodiafiltration and high flux hemodialysis in people with End-Stage Renal Disease, run by Ercan OK at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- post-dilution on-line hemodiafiltration and high flux hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jan 2007to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
- willingness to participate in the study with a written informed consent
Who cannot join
- To be scheduled for living donor renal transplantation
- To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- Pregnancy or lactating
- Current requirement for HD more than three times per week due to medical comorbidity
- GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
- Use of temporary catheter
- Insufficient vascular access (blood flow rate lower than 250 ml/min)
- Mental incompetence
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
FMC Clinics Turkey
Adana, 01000
Ege University School of Medicine
Bornova, İzmir, 35100
About this study
Official title: Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.
The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.
Read the detailed description
The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.
Seven hundred and eighty HD patients will be taken into the study. The study will last for two years with an intermediate analysis at the first year. The patients will be randomly placed in two groups:
- Post-dilution on-line hemodiafiltration,
- High-flux hemodialysis.
In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF. Substitution volume will be above 15 liters in hemodiafiltration sessions.
Echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.
- Conditions
- End-Stage Renal Disease
- Being tested
- post-dilution on-line hemodiafiltration, high flux hemodialysis
- Keywords
- end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, on-line hemodiafiltration, arterial stiffness, inflammation, life quality, left ventricular hypertrophy
- Medical subject headings
- Kidney Failure, Chronic, Inflammation, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-dilution on-line hemodiafiltrationProcedure or surgery
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
high flux hemodialysisProcedure or surgery
Also called High-flux hemodialysis
High-flux hemodialysis, 3 times a week 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Post-dilution on-line hemodiafiltration | Active comparator | Post-dilution on-line hemodiafiltration Receives: Procedure: post-dilution on-line hemodiafiltration |
| High-flux hemodialysis | Other | High-flux hemodialysis Receives: Procedure: high flux hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.
Measured: two years
Secondary outcomes (7)
cardiovascular mortality
Measured: two years
hospitalization rate
Measured: two years
intradialytic complications including hypotension and cramp
Measured: two years
health-related quality of life, depression burden, cognitive function
Measured: two years
required medications
Measured: two years
changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Measured: two years
postdialysis total body water determined by bioimpedance analysis
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2010
- Study completionMar 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ercan OK
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Responsible party
- Sponsor-investigator, Ercan OK, Ege University
- Investigators
- Ercan Ok, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411177
- Sponsor's protocol ID
- Ege0683
- Status last verified
- Sep 2013
- First submitted
- 12 Dec 2006
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)
- ClinicalTrials.gov ID
- NCT00411177
- Acronym / sponsor ID
- Ege0683
- Conditions
- End-Stage Renal Disease
- Keywords
- end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, on-line hemodiafiltration, arterial stiffness, inflammation, life quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Ercan OKUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Study start
- Jan 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Dec 2006 (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.
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.
The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.
Detailed description
The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.
Seven hundred and eighty HD patients will be taken into the study. The study will last for two years with an intermediate analysis at the first year. The patients will be randomly placed in two groups:
- Post-dilution on-line hemodiafiltration,
- High-flux hemodialysis.
In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF. Substitution volume will be above 15 liters in hemodiafiltration sessions.
Echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-dilution on-line hemodiafiltration | Active comparator | Procedure: post-dilution on-line hemodiafiltrationPost-dilution on-line hemodiafiltration |
| High-flux hemodialysis | Other | Procedure: high flux hemodialysisHigh-flux hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years
- on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
- willingness to participate in the study with a written informed consent
Key exclusion criteria (8 listed)
- To be scheduled for living donor renal transplantation
- To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- Pregnancy or lactating
- Current requirement for HD more than three times per week due to medical comorbidity
- GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
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 |
|---|---|---|
| post-dilution on-line hemodiafiltrationpost-dilution on-line hemodiafiltration, 3 times a week 4 hours | Procedure or surgery | Post-dilution on-line hemodiafiltration |
| high flux hemodialysisAlso: High-flux hemodialysisHigh-flux hemodialysis, 3 times a week 4 hours | Procedure or surgery | High-flux hemodialysis |
Primary outcome
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.
Time frame: two years
7 secondary outcomes
cardiovascular mortality
Time frame: two years
hospitalization rate
Time frame: two years
intradialytic complications including hypotension and cramp
Time frame: two years
health-related quality of life, depression burden, cognitive function
Time frame: two years
required medications
Time frame: two years
changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Time frame: two years
postdialysis total body water determined by bioimpedance analysis
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
Related trials for End-Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Ercan Ok, MD principal investigator
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing post-dilution on-line hemodiafiltration and high flux hemodialysis in people with End-Stage Renal Disease, run by Ercan OK at 2 sites in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization. (time frame: two years). 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 9 Sep 2013.