End-stage Renal DiseasePhase 4NCT00295191
Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in HD Patients(EGESTUDY)
A Phase 4 study testing high-flux membrane, low-flux membrane and conventional dialysate in people with End-stage Renal Disease and Hemodialysis, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-stage Renal Disease, Hemodialysis
- What is being tested?
- high-flux membrane, low-flux membrane and conventional dialysate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Nov 2005to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years
- On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
FMC Clinics
Bornova, İzmir, 35100
Ege University School of Medicine
Bornova-Izmir, 35100
About this study
Official title: Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in Hemodialysis Patients: Prospective, Randomized, Controlled Study
This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.
Read the detailed description
This proposed prospective, randomized, controlled study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.
Their beneficial effects may be directly represented by significantly reduced cardiovascular morbidity and mortality. The proposed additional investigations, such as a possible decrease in the progression of coronary artery calcification and carotid artery intima-media thickness, will help us to understand the mechanisms of the expected reduction or serve as surrogate markers of atherosclerosis, in case the benefit of the interventions cannot be proven with statistical significance.
Seven hundred and four hemodialysis patients treated in Ege University Hospital Dialysis Unit and eight FMC Clinics will be enrolled into the study (3-year follow-up; percentage of yearly expected end-point 10%;expected event-free survival rate for control group during three year is 72.9%,a bilateral alpha risk equal to 5%; an 90% power to detect an increase of 15% in event-free survival at the end of 3-year follow-up in favor of the each intervention group). Annual drop-out rate is estimated as %15-20.
It is designed as 2x2 factorial; the cases, first, will be randomized to high flux dialyser and low flux dialyser arms; then, they will be re-randomized to ultra pure (online-produced by using Diasafe and checked by endotoxin measurement) and standard dialysate arms. The study will last three years; an intermediate analysis will be performed at the 18th month.
Primary end-point is the composite of cardiovascular mortality and myocardial infarction, stroke, revascularization, unstable angina pectoris requiring hospitalization (at 18 ad 36th month).
Secondary end-points are overall mortality, progression of coronary artery calcification, progression of carotid artery intima-media thickness, changes in post-dialysis body weight and upper mid-arm circumference, hematocrit and related rHu-EPO doses, changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.
At the 0-18-36 months, coronary artery calcification will be assessed by multi-slice CT and carotid artery intima-media thickness by B-mode ultrasonography. Lipids and CRP will be measured in every three months.
- Conditions
- End-stage Renal Disease, Hemodialysis
- Being tested
- high-flux membrane, low-flux membrane, conventional dialysate, ultrapure dialysate
- Keywords
- end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, ultrapure dialysate, coronary vascular calcifications, carotid intima-media thickness, atherosclerosis
- Medical subject headings
- Kidney Failure, Chronic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flux membraneProcedure or surgery
high-flux dialyser
low-flux membraneProcedure or surgery
low-flux dialyser
conventional dialysateProcedure or surgery
conventional dialysate
ultrapure dialysateProcedure or surgery
ultrapure dialysate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | high-flux dialyser Receives: Procedure: high-flux membrane |
| 2 | Active comparator | low-flux dialyser Receives: Procedure: low-flux membrane |
| 3 | Active comparator | conventional dialysate Receives: Procedure: conventional dialysate |
| 4 | Active comparator | ultrapure dialysate Receives: Procedure: ultrapure dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization
Measured: three years
Secondary outcomes (7)
overall mortality
Measured: three years
progression of coronary artery calcification
Measured: three years
progression of carotid artery intima-media thickness
Measured: three years
changes in post-dialysis body weight
Measured: three years
changes in upper mid-arm circumference
Measured: three years
changes in hematocrit and related rHu-EPO doses
Measured: three years
changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Responsible party
- Principal investigator, Ercan OK, Ege University
- Investigators
- Ercan Ok, M.D, Principal investigator, Ege University School of Medicine Nephrology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295191
- Sponsor's protocol ID
- EGE99803466003
- Status last verified
- Oct 2011
- First submitted
- 22 Feb 2006
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ok ES, Asci G, Toz H, Ritz E, Kircelli F, Sever MS, Ozkahya M, Sipahi S, Dheir H, Bozkurt D, Omer Z, Sahin OZ, Ertilav M, Ok E. Glycated hemoglobin predicts overall and cardiovascular mortality in non-diabetic hemodialysis patients. Clin Nephrol. 2014 Sep;82(3):173-80. doi: 10.5414/cn108251.
PubMed 25079862
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in Hemodialysis Patients: Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT00295191
- Acronym / sponsor ID
- EGE99803466003
- Conditions
- End-stage Renal Disease, Hemodialysis
- Keywords
- end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, ultrapure dialysate, coronary vascular calcifications, carotid intima-media thickness, atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Study start
- Nov 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Feb 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 investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.
Detailed description
This proposed prospective, randomized, controlled study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.
Their beneficial effects may be directly represented by significantly reduced cardiovascular morbidity and mortality. The proposed additional investigations, such as a possible decrease in the progression of coronary artery calcification and carotid artery intima-media thickness, will help us to understand the mechanisms of the expected reduction or serve as surrogate markers of atherosclerosis, in case the benefit of the interventions cannot be proven with statistical significance.
Seven hundred and four hemodialysis patients treated in Ege University Hospital Dialysis Unit and eight FMC Clinics will be enrolled into the study (3-year follow-up; percentage of yearly expected end-point 10%;expected event-free survival rate for control group during three year is 72.9%,a bilateral alpha risk equal to 5%; an 90% power to detect an increase of 15% in event-free survival at the end of 3-year follow-up in favor of the each intervention group). Annual drop-out rate is estimated as %15-20.
It is designed as 2x2 factorial; the cases, first, will be randomized to high flux dialyser and low flux dialyser arms; then, they will be re-randomized to ultra pure (online-produced by using Diasafe and checked by endotoxin measurement) and standard dialysate arms. The study will last three years; an intermediate analysis will be performed at the 18th month.
Primary end-point is the composite of cardiovascular mortality and myocardial infarction, stroke, revascularization, unstable angina pectoris requiring hospitalization (at 18 ad 36th month).
Secondary end-points are overall mortality, progression of coronary artery calcification, progression of carotid artery intima-media thickness, changes in post-dialysis body weight and upper mid-arm circumference, hematocrit and related rHu-EPO doses, changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.
At the 0-18-36 months, coronary artery calcification will be assessed by multi-slice CT and carotid artery intima-media thickness by B-mode ultrasonography. Lipids and CRP will be measured in every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: high-flux membranehigh-flux dialyser |
| 2 | Active comparator | Procedure: low-flux membranelow-flux dialyser |
| 3 | Active comparator | Procedure: conventional dialysateconventional dialysate |
| 4 | Active comparator | Procedure: ultrapure dialysateultrapure dialysate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 80 years
- On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- Willingness to participate in the study with a written informed consent.
Key exclusion criteria (2 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
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 membranehigh-flux dialyser | Procedure or surgery | 1 |
| low-flux membranelow-flux dialyser | Procedure or surgery | 2 |
| conventional dialysateconventional dialysate | Procedure or surgery | 3 |
| ultrapure dialysateultrapure dialysate | Procedure or surgery | 4 |
Primary outcome
cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization
Time frame: three years
7 secondary outcomes
overall mortality
Time frame: three years
progression of coronary artery calcification
Time frame: three years
progression of carotid artery intima-media thickness
Time frame: three years
changes in post-dialysis body weight
Time frame: three years
changes in upper mid-arm circumference
Time frame: three years
changes in hematocrit and related rHu-EPO doses
Time frame: three years
changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.
Time frame: three 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 4 Oct 2011.
- Derived from this study: PubMed 25079862Ok ES, Asci G, Toz H, Ritz E, Kircelli F, Sever MS, Ozkahya M, Sipahi S, Dheir H, Bozkurt D, Omer Z, Sahin OZ, Ertilav M, Ok E. Glycated hemoglobin predicts overall and cardiovascular mortality in non-diabetic hemodialysis patients. Clin Nephrol. 2014 Sep;82(3):173-80. doi: 10.5414/cn108251.
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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.
Ercan Ok, M.D principal investigator
Ege University School of Medicine Nephrology Department
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 high-flux membrane, low-flux membrane and conventional dialysate in people with End-stage Renal Disease and Hemodialysis, run by Ege University 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 2 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 4 Oct 2011. 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?
cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization (time frame: three years). 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 NCT00295191, which also lists 1 linked publication.
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 4 Oct 2011.