End-Stage Renal DiseasePhase 4NCT00413803
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis
A Phase 4 study testing 4-hour thrice weekly in center hemodialysis and 8-hour thrice weekly in center hemodialysis in people with End-Stage Renal Disease and Hemodialysis, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Hemodialysis
- What is being tested?
- 4-hour thrice weekly in center hemodialysis and 8-hour thrice weekly in center hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Dec 2006to Feb 2008
- 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
- Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
- Mental incompetence
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
FMC Turkey Clinics
Adana, 01100
Ege University School of Medicine Nephrology Department
Izmir, 35100
About this study
Official title: Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study
The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.
Read the detailed description
The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:
- Four-hour dialysis session, blood flow rate 300-400 ml/min
- Eight-hours dialysis session, blood flow rate 200-250 ml/min
Sample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Being tested
- 4-hour thrice weekly in center hemodialysis, 8-hour thrice weekly in center hemodialysis
- Keywords
- Hemodialysis, Nocturnal dialysis, Cardiovascular disease, Quality of Life, left ventricular hypertrophy
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-hour thrice weekly in center hemodialysisProcedure or surgery
conventional hemodialysis
8-hour thrice weekly in center hemodialysisProcedure or surgery
long dialysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Four-hour dialysis session, blood flow rate 300-400 ml/min Receives: Procedure: 4-hour thrice weekly in center hemodialysis |
| 2 | Active comparator | Eight-hours dialysis session, blood flow rate 200-250 ml/min Receives: Procedure: 8-hour thrice weekly in center hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
total mortality
Measured: one year
Secondary outcomes (9)
cardiovascular mortality
Measured: one year
changes in health-related quality of life, depression burden, cognitive function
Measured: one year
required medications
Measured: one year
total cost
Measured: one year
changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness,upper mid-arm circumference,hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Measured: one year
hospitalization rate
Measured: one year
Vascular access patency
Measured: one year
post-dialysis body weight and total body water
Measured: one year
arrythmia episodes determined by Holter-ECG
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 posted20 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Investigators
- Ercan Ok, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413803
- Sponsor's protocol ID
- 06-5.1/8
- Status last verified
- Aug 2009
- First submitted
- 19 Dec 2006
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.
PubMed 22172590
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study
- ClinicalTrials.gov ID
- NCT00413803
- Acronym / sponsor ID
- 06-5.1/8
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Keywords
- Hemodialysis, Nocturnal dialysis, Cardiovascular disease, Quality of Life, left ventricular hypertrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 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.
The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.
Detailed description
The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:
- Four-hour dialysis session, blood flow rate 300-400 ml/min
- Eight-hours dialysis session, blood flow rate 200-250 ml/min
Sample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: 4-hour thrice weekly in center hemodialysisFour-hour dialysis session, blood flow rate 300-400 ml/min |
| 2 | Active comparator | Procedure: 8-hour thrice weekly in center hemodialysisEight-hours dialysis session, blood flow rate 200-250 ml/min |
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 |
|---|---|---|
| 4-hour thrice weekly in center hemodialysisconventional hemodialysis | Procedure or surgery | 1 |
| 8-hour thrice weekly in center hemodialysislong dialysis | Procedure or surgery | 2 |
Primary outcome
total mortality
Time frame: one year
9 secondary outcomes
cardiovascular mortality
Time frame: one year
changes in health-related quality of life, depression burden, cognitive function
Time frame: one year
required medications
Time frame: one year
total cost
Time frame: one year
changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness,upper mid-arm circumference,hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Time frame: one year
hospitalization rate
Time frame: one year
Vascular access patency
Time frame: one year
post-dialysis body weight and total body water
Time frame: one year
arrythmia episodes determined by Holter-ECG
Time frame: one year
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 Aug 2009.
- Derived from this study: PubMed 22172590Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.
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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, 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 4-hour thrice weekly in center hemodialysis and 8-hour thrice weekly in center hemodialysis 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 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 4 Aug 2009. 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?
total 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 NCT00413803, 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 Aug 2009.