Chronic Kidney DiseaseINVEST-PDNCT00433264
The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis
An observational study of Chronic Kidney Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- peritoneal dialysis
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2007to Dec 2008
- Phase
- Observational
- 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
Study population: Tertiary referral center university hospital
Who may be able to join
- age > 18
- Maintenance peritoneal dialysis
Who cannot join
- No informed consent
- Peritonitis
Trial locations and contacts
1 site in 1 country.
About this study
Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. This relation is present from early stages of chronic kidney disease on.
Several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. In peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking.
The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients
- Conditions
- Chronic Kidney Disease
- Being tested
- peritoneal dialysis
- Keywords
- peritoneal dialysis, endothelium, endothelial dysfunction
- 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
Also called individualised
individualised
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Bjorn Meijers, MD, Principal investigator, UZ LeuvenKathleen Claes, MD, Principal investigator, UZ LeuvenPieter Evenepoel, MD, PhD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433264
- Sponsor's protocol ID
- ML3645
- Acronym
- INVEST-PD
- Status last verified
- Mar 2009
- First submitted
- 7 Feb 2007
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00433264
- Acronym / sponsor ID
- INVEST-PD / ML3645
- Conditions
- Chronic Kidney Disease
- Keywords
- peritoneal dialysis, endothelium, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Feb 2007 (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.
Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. This relation is present from early stages of chronic kidney disease on.
Several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. In peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking.
The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary referral center university hospital
Key inclusion criteria (2 listed)
- age > 18
- Maintenance peritoneal dialysis
Key exclusion criteria (2 listed)
- No informed consent
- Peritonitis
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 dialysisAlso: individualisedindividualised | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 5 Mar 2009.
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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.
Bjorn Meijers, MD principal investigator
UZ Leuven
Kathleen Claes, MD principal investigator
UZ Leuven
Pieter Evenepoel, MD, PhD study director
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Universitaire Ziekenhuizen KU Leuven 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 2 inclusion and 2 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 5 Mar 2009. 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.
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 5 Mar 2009.