Risk FactorsNCT00888030
P-cresol: Correlation With Glomerular Filtration Rate and Outcome in Chronic Kidney Disease
An observational study of Risk Factors and Renal Progression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and intervention for CKD complication is important to retard renal progression. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Factors, Renal Progression, Death
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2006to Dec 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All CKD patients attended at out-patient department of nephrology were included for analysis. The inclusion criteria were adults aged > 18 y/o or < 80 y/o; estimated GFR or CCR < 60 ml/min; no spontaneous renal improvement or progression in past 3 months.
Who may be able to join
- All CKD patients attended at out-patient department of nephrology were included for analysis.
- The inclusion criteria were adults aged > 18 y/o or < 80 y/o
- Estimated GFR or CCR < 60 ml/min
- No spontaneous renal improvement or progression in past 3 months.
Who cannot join
- Recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) in past 3 months
- Recent infections requiring admission in past 3 months
- Uncontrolled hypertension
- Serum albumin level < 2.5mg/dL
- Unwilling to participate in the trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Nephrology,Chang Gung Memorial Hospital
Keelung, 204
About this study
End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and intervention for CKD complication is important to retard renal progression. However, "traditional uremic toxin" or "small water-soluble molecules" are poorly correlated with the renal function, uremic symptoms and outcomes of CKD patients.
Putative protein-bound solute, p-cresol, is accumulated in ESRD patients receiving dialysis therapy. This uremic solute was associated with endothelial dysfunction, immune dysregulation and can predict outcome in hemodialysis patient. P-cresol inhibits endothelial cell proliferation and endothelial response to inflammatory cytokines. In vitro, p-cresol decreases leukocyte transendotherliar migratory function and inhibit production of phagocyte reactive species. Clinically, p-cresol plays a pathophysiological role in the uremic toxicity. High free serum level of p-cresol is associated with mortality in hemodialysis patients.
Read more
Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.
Value of p-cresol in different stages of CRF is still unknown. Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.
The principal aim of this prospective cohort study is to investigate the association between total serum levels of p-cresol and the glomerular filtration rate. The correlation of level of p-cresol and morbidity-mortality in CKD patients will be also evaluated.
To determine the relationship, patients of nephrology clinic with a diagnosis of CKD were enrolled in this prospective study and follow-up for 1-year period. The association between total and free serum levels of p-cresol and the glomerular filtration rate were evaluated in CKD patients. The p-cresol level was correlated with other many inflammatory markers (white blood cell counts, ferritin, hs-crp, leptin) and also with the hospitalization rate secondary to cardiovascular and infectious event. The renal outcome and all-cause mortality was assessed. Determination of this relationship can help to establish an accurate marker for early detection of CKD and also its prognostic role in CKD patients.
- Conditions
- Risk Factors, Renal Progression, Death
- Being tested
- there are no interventions currently listed for this study
- Keywords
- p-cresol, indoxyl sulfate, chronic kidney disease, outcome
- Medical subject headings
- Death, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there are no interventions currently listed for this studyOther
| Study group | Role | What they receive |
|---|---|---|
| 2 | CKD patients with normal p-cresol Receives: Other: there are no interventions currently listed for this study | |
| 3 | CKD patient with normal indoxyl sulfate Receives: Other: there are no interventions currently listed for this study | |
| 4 | CKD patients with high indoxyl sulfate Receives: Other: there are no interventions currently listed for this study | |
| 1 | CKD patients with high p cresol Receives: Other: there are no interventions currently listed for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
end stage renal disease, reduction of eGFR by 50% and death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Risk FactorsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, iwenwu, Chang Gung Memorial Hospital
- Investigators
- Iwen Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888030
- Sponsor's protocol ID
- IWW-0003
- Status last verified
- Sep 2012
- First submitted
- 22 Apr 2009
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meijers BK, Bammens B, De Moor B, Verbeke K, Vanrenterghem Y, Evenepoel P. Free p-cresol is associated with cardiovascular disease in hemodialysis patients. Kidney Int. 2008 May;73(10):1174-80. doi: 10.1038/ki.2008.31. Epub 2008 Feb 27.
PubMed 18305466Atoh K, Itoh H, Haneda M. Serum indoxyl sulfate levels in patients with diabetic nephropathy: relation to renal function. Diabetes Res Clin Pract. 2009 Feb;83(2):220-6. doi: 10.1016/j.diabres.2008.09.053. Epub 2008 Nov 22.
PubMed 19027976Meijers BK, de Loor H, Verbeke K, Evenepoel P. p-Cresol for better or worse: but what are we measuring? Kidney Int. 2006 Jul;70(1):232; author reply 232-3. doi: 10.1038/sj.ki.5001530. No abstract available.
PubMed 16810293
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P-cresol: Correlation With Glomerular Filtration Rate and Outcome in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00888030
- Acronym / sponsor ID
- IWW-0003
- Conditions
- Risk Factors, Renal Progression, Death
- Keywords
- p-cresol, indoxyl sulfate, chronic kidney disease, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Apr 2009 (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.
End-stage renal disease is a global epidemia with an estimated incidence of 7% per year and high morbidity-mortality rate. Early detection of chronic kidney disease (CKD) and intervention for CKD complication is important to retard renal progression. However, "traditional uremic toxin" or "small water-soluble molecules" are poorly correlated with the renal function, uremic symptoms and outcomes of CKD patients.
Putative protein-bound solute, p-cresol, is accumulated in ESRD patients receiving dialysis therapy. This uremic solute was associated with endothelial dysfunction, immune dysregulation and can predict outcome in hemodialysis patient. P-cresol inhibits endothelial cell proliferation and endothelial response to inflammatory cytokines. In vitro, p-cresol decreases leukocyte transendotherliar migratory function and inhibit production of phagocyte reactive species. Clinically, p-cresol plays a pathophysiological role in the uremic toxicity. High free serum level of p-cresol is associated with mortality in hemodialysis patients.
Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.
Value of p-cresol in different stages of CRF is still unknown. Information of p-cresol in CKD patients is not available. The investigators hypothesized p-cresol can be accumulated in early CKD and have a positive correlation with the morbidity- mortality of CKD patients.
The principal aim of this prospective cohort study is to investigate the association between total serum levels of p-cresol and the glomerular filtration rate. The correlation of level of p-cresol and morbidity-mortality in CKD patients will be also evaluated.
To determine the relationship, patients of nephrology clinic with a diagnosis of CKD were enrolled in this prospective study and follow-up for 1-year period. The association between total and free serum levels of p-cresol and the glomerular filtration rate were evaluated in CKD patients. The p-cresol level was correlated with other many inflammatory markers (white blood cell counts, ferritin, hs-crp, leptin) and also with the hospitalization rate secondary to cardiovascular and infectious event. The renal outcome and all-cause mortality was assessed. Determination of this relationship can help to establish an accurate marker for early detection of CKD and also its prognostic role in CKD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | – | Other: there are no interventions currently listed for this studyCKD patients with normal p-cresol |
| 3 | – | Other: there are no interventions currently listed for this studyCKD patient with normal indoxyl sulfate |
| 4 | – | Other: there are no interventions currently listed for this studyCKD patients with high indoxyl sulfate |
| 1 | – | Other: there are no interventions currently listed for this studyCKD patients with high p cresol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All CKD patients attended at out-patient department of nephrology were included for analysis. The inclusion criteria were adults aged > 18 y/o or < 80 y/o; estimated GFR or CCR < 60 ml/min; no spontaneous renal improvement or progression in past 3 months.
Key inclusion criteria (4 listed)
- All CKD patients attended at out-patient department of nephrology were included for analysis.
- The inclusion criteria were adults aged > 18 y/o or < 80 y/o
- Estimated GFR or CCR < 60 ml/min
- No spontaneous renal improvement or progression in past 3 months.
Key exclusion criteria (5 listed)
- Recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) in past 3 months
- Recent infections requiring admission in past 3 months
- Uncontrolled hypertension
- Serum albumin level < 2.5mg/dL
- Unwilling to participate in the trial.
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 |
|---|---|---|
| there are no interventions currently listed for this study | Other | 1, 2, 3, 4 |
Primary outcome
end stage renal disease, reduction of eGFR by 50% and death
Time frame: 1 year
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 6 Sep 2012.
- Background: PubMed 18305466Meijers BK, Bammens B, De Moor B, Verbeke K, Vanrenterghem Y, Evenepoel P. Free p-cresol is associated with cardiovascular disease in hemodialysis patients. Kidney Int. 2008 May;73(10):1174-80. doi: 10.1038/ki.2008.31. Epub 2008 Feb 27.
- Background: PubMed 19027976Atoh K, Itoh H, Haneda M. Serum indoxyl sulfate levels in patients with diabetic nephropathy: relation to renal function. Diabetes Res Clin Pract. 2009 Feb;83(2):220-6. doi: 10.1016/j.diabres.2008.09.053. Epub 2008 Nov 22.
- Background: PubMed 16810293Meijers BK, de Loor H, Verbeke K, Evenepoel P. p-Cresol for better or worse: but what are we measuring? Kidney Int. 2006 Jul;70(1):232; author reply 232-3. doi: 10.1038/sj.ki.5001530. No abstract available.
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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.
Iwen Wu, MD principal investigator
Chang Gung Memorial Hospital
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 Risk Factors and Renal Progression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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 6 Sep 2012. 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 Taiwan. 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?
end stage renal disease, reduction of eGFR by 50% and death (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888030, which also lists 3 linked publications.
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 6 Sep 2012.