HemodialysisNCT00752583
Peritoneal Dialysis Versus Haemodialysis
A study testing Peritoneal dialysis and Haemodialysis in people with Hemodialysis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Study in order to quantify toxin removal during dialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Peritoneal dialysis and Haemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Nov 2008to 31 Dec 2015
- 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
- Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD
- Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis.
- Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study in Order to Quantify Solute Removal in Peritoneal Dialysis Versus Haemodialysis
Study in order to quantify toxin removal during dialysis
- Conditions
- Hemodialysis
- Being tested
- Peritoneal dialysis, Haemodialysis
- Keywords
- Chronic renal insufficiency (patients under dialysis)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal dialysisProcedure or surgery
Blood, urine and dialysate sampling
HaemodialysisProcedure or surgery
Blood, urine and dialysate sampling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peritoneal dialysis Receives: Procedure: Peritoneal dialysis |
| 2 | Active comparator | Haemodialysis Receives: Procedure: Haemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration of toxin removal efficiency
Measured: After 1 week and after 1, 3, 6, 9, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study start7 Nov 2008
- Primary completion30 Nov 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond Vanholder, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752583
- Sponsor's protocol ID
- 2008/232
- Status last verified
- Dec 2022
- First submitted
- 12 Sep 2008
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study in Order to Quantify Solute Removal in Peritoneal Dialysis Versus Haemodialysis
- ClinicalTrials.gov ID
- NCT00752583
- Acronym / sponsor ID
- 2008/232
- Conditions
- Hemodialysis
- Keywords
- Chronic renal insufficiency (patients under dialysis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 7 Nov 2008 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 15 Sep 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.
Study in order to quantify toxin removal during dialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Peritoneal dialysisPeritoneal dialysis |
| 2 | Active comparator | Procedure: HaemodialysisHaemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD
- Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis.
- Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Peritoneal dialysisBlood, urine and dialysate sampling | Procedure or surgery | 1 |
| HaemodialysisBlood, urine and dialysate sampling | Procedure or surgery | 2 |
Primary outcome
Registration of toxin removal efficiency
Time frame: After 1 week and after 1, 3, 6, 9, 12, 18 and 24 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 15 Dec 2022.
- 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 Peritoneal dialysis and Haemodialysis in people with Hemodialysis, 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 3 inclusion and 0 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 15 Dec 2022. 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?
Registration of toxin removal efficiency (time frame: After 1 week and after 1, 3, 6, 9, 12, 18 and 24 months). 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 15 Dec 2022.