Chronic Renal FailureNCT00766792
Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
A study testing Nocturnal dialysis and Standard dialysis in people with Chronic Renal Failure, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Nocturnal dialysis and Standard dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2005to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.
- Conditions
- Chronic Renal Failure
- Being tested
- Nocturnal dialysis, Standard dialysis
- 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.
Nocturnal dialysisProcedure or surgery
Switch to nocturnal dialysis (3 times 480 min/week)
Standard dialysisProcedure or surgery
Standard dialysis (3 times 240-270 min/week)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nocturnal dialysis Receives: Procedure: Nocturnal dialysis |
| 2 | Active comparator | Standard dialysis Receives: Procedure: Standard dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis?
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startDec 2005
- Primary completionJul 2008
- Study completionJul 2008
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Raymond Vanholder, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766792
- Sponsor's protocol ID
- 2005/288
- Status last verified
- Oct 2008
- First submitted
- 3 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis
- ClinicalTrials.gov ID
- NCT00766792
- Acronym / sponsor ID
- 2005/288
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Oct 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.
Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Nocturnal dialysisNocturnal dialysis |
| 2 | Active comparator | Procedure: Standard dialysisStandard dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age > 18 years
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| Nocturnal dialysisSwitch to nocturnal dialysis (3 times 480 min/week) | Procedure or surgery | 1 |
| Standard dialysisStandard dialysis (3 times 240-270 min/week) | Procedure or surgery | 2 |
Primary outcome
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis?
Time frame: 30 weeks
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 31 Oct 2008.
- Website of the 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 Nocturnal dialysis and Standard dialysis 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 1 inclusion and 1 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 31 Oct 2008. 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 removal of uremic toxins - nocturnal versus standard dialysis? (time frame: 30 weeks). 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 31 Oct 2008.