HemodialysisPhase 4ESHOLNCT00694031
Survival Study in Patients Undergoing On-line Hemodiafiltration
A Phase 4 study testing Hemodialysis and On-line hemodiafiltration in people with Hemodialysis, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Hemodialysis and On-line hemodiafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 906 participants
- Where
- 2 sitesSpain
- Study dates
- May 2007to Jan 2012
- 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
- Age 18 and older
- Currently undergoing hemodialysis
- Clinical stability
- Stable vascular access
Who cannot join
- Chronic inflammatory diseases
- Liver cirrhosis
- Malignancies
- Chronic immunosuppressant or antiinflammatory use
- Dialysis through temporary catheter or single puncture
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
CSU Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.
- Conditions
- Hemodialysis
- Being tested
- Hemodialysis, On-line hemodiafiltration
- Keywords
- Mortality, Convective therapies, On-line Hemodiafiltration, Dialysis Adequacy, Age 18 or older, Undergoing hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisProcedure or surgery
3 times per week
On-line hemodiafiltrationProcedure or surgery
3 times per week
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Hemodialysis Receives: Procedure: Hemodialysis |
| B | Experimental | On-line hemodiafiltration Receives: Procedure: On-line hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Nefrologia
- Responsible party
- Principal investigator, Francisco Maduell, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694031
- Sponsor's protocol ID
- ESHOL
- Acronym
- ESHOL
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2008
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Foraster A, Soler J, Galceran JM, Martinez-Castelao A; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology. Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study. J Nephrol. 2011 Mar-Apr;24(2):196-202. doi: 10.5301/jn.2010.386.
PubMed 20602331Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.
PubMed 23411788
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-line Hemodiafiltration
- ClinicalTrials.gov ID
- NCT00694031
- Acronym / sponsor ID
- ESHOL / ESHOL
- Conditions
- Hemodialysis
- Keywords
- Mortality, Convective therapies, On-line Hemodiafiltration, Dialysis Adequacy, Age 18 or older, Undergoing hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 906 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Societat Catalana de Nefrologia
- Study start
- May 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Jun 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.
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: HemodialysisHemodialysis |
| B | Experimental | Procedure: On-line hemodiafiltrationOn-line hemodiafiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and older
- Currently undergoing hemodialysis
- Clinical stability
- Stable vascular access
Key exclusion criteria (5 listed)
- Chronic inflammatory diseases
- Liver cirrhosis
- Malignancies
- Chronic immunosuppressant or antiinflammatory use
- Dialysis through temporary catheter or single puncture
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 |
|---|---|---|
| Hemodialysis3 times per week | Procedure or surgery | A |
| On-line hemodiafiltration3 times per week | Procedure or surgery | B |
Primary outcome
Survival
Time frame: 36 months
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 28 Feb 2014.
- Background: PubMed 20602331Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Foraster A, Soler J, Galceran JM, Martinez-Castelao A; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology. Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study. J Nephrol. 2011 Mar-Apr;24(2):196-202. doi: 10.5301/jn.2010.386.
- Background: PubMed 23411788Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemodialysis and On-line hemodiafiltration in people with Hemodialysis, run by Hospital Clinic of Barcelona at 2 sites in Spain.
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 4 inclusion and 5 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 28 Feb 2014. 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 Spain. 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?
Survival (time frame: 36 months). 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 NCT00694031, which also lists 2 linked publications.
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 28 Feb 2014.