Chronic Renal FailureNCT00337831
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
A study testing Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration in people with Chronic Renal Failure, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- May 2006to May 2007
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable on hemodialysis >= 6 months
- of which presently on high-flux HD >= 1 month
- 18 years < age < 85 years
- blood flow rate >= 300ml/min
Who cannot join
- expected survival < 1 year
- expected transplant within < 1 year
- infectious diseases
- pregnancy
- chronic inflammation condition
- treated with single needle dialysis
- presently treated with hemodiafiltration or low-flux hemodiafiltration
- expected intradialytic body weight gain >= 4kg
Trial locations and contacts
1 site in 1 country.
About this study
Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).
- Conditions
- Chronic Renal Failure
- Being tested
- Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
- 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.
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltrationProcedure or surgery
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
Measured: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins?
Measured: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Corporate Research, Sweden
- Investigators
- Raymond Vanholder, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337831
- Sponsor's protocol ID
- 2006/127
- Status last verified
- Jun 2011
- First submitted
- 15 Jun 2006
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
- ClinicalTrials.gov ID
- NCT00337831
- Acronym / sponsor ID
- 2006/127
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Gambro Corporate Research, Sweden
- Study start
- May 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 16 Jun 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.
Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stable on hemodialysis >= 6 months
- of which presently on high-flux HD >= 1 month
- 18 years < age < 85 years
- blood flow rate >= 300ml/min
Key exclusion criteria (8 listed)
- expected survival < 1 year
- expected transplant within < 1 year
- infectious diseases
- pregnancy
- chronic inflammation condition
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 |
|---|---|---|
| Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltrationPerformance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed. | Procedure or surgery | – |
Primary outcome
To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
Time frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins?
Time frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.
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 30 Jun 2011.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Raymond Vanholder, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration in people with Chronic Renal Failure, run by University Hospital, Ghent at 1 site in Belgium.
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 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 30 Jun 2011. 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 Belgium. 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.
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?
To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood? (time frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min.). The study lists 2 primary outcomes in all. 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 30 Jun 2011.