Renal Insufficiency, ChronicNCT01874210
Study on Colonic Fermentation in Chronic Kidney Disease Patients
An observational study of Renal Insufficiency, Chronic, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2008to May 2016
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
Who may be able to join
- Age ≥ 18 and ≤ 95 years
- Treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
- Written informed consent
Who cannot join
- History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy)
- History of colonic surgery
- Recipient of a renal or other solid organ transplant
- Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.
- Conditions
- Renal Insufficiency, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis | Hemodialysis patients | |
| Control | 1. Household contacts on the same diet 2. Healthy unrelated controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in fecal metabolite profile (Chronic kidney disease vs. control)
difference in fecal metabolite profile between chronic kidney disease patients and control group
Measured: baseline
Secondary outcomes (1)
difference in fecal metabolite profile depending on dialysis modality
difference in fecal metabolite profile between hemodialysis patients and peritoneal patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startFeb 2008
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruben Poesen, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenBjörn Meijers, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenKristin Verbeke, Pharm PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenPieter Evenepoel, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874210
- Sponsor's protocol ID
- S51367
- Status last verified
- May 2016
- First submitted
- 6 Jun 2013
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Colonic Fermentation in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT01874210
- Acronym / sponsor ID
- S51367
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jun 2013 (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.
Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | – | –Hemodialysis patients |
| Control | – | –1. Household contacts on the same diet 2. Healthy unrelated controls |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
Key inclusion criteria (3 listed)
- Age ≥ 18 and ≤ 95 years
- Treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months
- Written informed consent
Key exclusion criteria (4 listed)
- History of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy)
- History of colonic surgery
- Recipient of a renal or other solid organ transplant
- Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks
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
difference in fecal metabolite profile (Chronic kidney disease vs. control)
Time frame: baseline
difference in fecal metabolite profile between chronic kidney disease patients and control group
1 secondary outcome
difference in fecal metabolite profile depending on dialysis modality
Time frame: baseline
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 18 May 2016.
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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.
Ruben Poesen, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Björn Meijers, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Kristin Verbeke, Pharm PhD principal investigator
Universitaire Ziekenhuizen KU 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 Renal Insufficiency, Chronic, 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 4 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 18 May 2016. 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?
difference in fecal metabolite profile (Chronic kidney disease vs. control) (time frame: baseline). 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 18 May 2016.