Complication of Peritoneal DialysisNCT01306149
Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients
An observational study of Complication of Peritoneal Dialysis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aims of this study are 1. To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules', and protein bound URM in incident peritoneal dialysis (PD) patients. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Peritoneal Dialysis
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2002to 31 Jan 2017
- 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: Incident peritoneal dialysis patients
Who may be able to join
- Incident PD patients, defined as patients who started on PD as first renal replacement therapy less than 8 weeks before inclusion
- written informed consent
- age > 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study
The aims of this study are
- To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules', and protein bound URM in incident peritoneal dialysis (PD) patients.
- To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
- To evaluate the natural history of biochemical parameters of mineral metabolism in incident PD patients.
- Conditions
- Complication of Peritoneal Dialysis
- Keywords
- biochemical parameters, mineral metabolism, protein-bound uremic retention solutes, incident PD patients
What is being measured
The primary outcome is the main question the study is designed to answer.
natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins
To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules, and protein bound URM in incident peritoneal dialysis (PD) patients.
Measured: 15 years
Secondary outcomes (1)
determinants of generation rate of uremic retention solutes
To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
Measured: 15 years on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJul 2002
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Peritoneal DialysisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Björn Meijers, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Pieter Evenepoel, MD,PhD, Principal investigator, University Hospital, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306149
- Sponsor's protocol ID
- FWO01-03-21
- Status last verified
- Oct 2017
- First submitted
- 23 Feb 2011
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT01306149
- Acronym / sponsor ID
- FWO01-03-21
- Conditions
- Complication of Peritoneal Dialysis
- Keywords
- biochemical parameters, mineral metabolism, protein-bound uremic retention solutes, incident PD patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2002 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 1 Mar 2011 (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.
The aims of this study are
- To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules', and protein bound URM in incident peritoneal dialysis (PD) patients.
- To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
- To evaluate the natural history of biochemical parameters of mineral metabolism in incident PD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident peritoneal dialysis patients
Key inclusion criteria (3 listed)
- Incident PD patients, defined as patients who started on PD as first renal replacement therapy less than 8 weeks before inclusion
- written informed consent
- age > 18 years old
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.
Primary outcome
natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins
Time frame: 15 years
To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules, and protein bound URM in incident peritoneal dialysis (PD) patients.
1 secondary outcome
determinants of generation rate of uremic retention solutes
Time frame: 15 years on average
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 25 Oct 2017.
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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.
Pieter Evenepoel, MD,PhD principal investigator
University Hospital, Leuven, Belgium
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 Complication of Peritoneal Dialysis, 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 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 25 Oct 2017. 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?
natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins (time frame: 15 years). 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 25 Oct 2017.