Chronic Kidney DiseaseNCT00395005
Correlation of Urinary Kallikrein With Cytokines, Proteinuria and Renal Function in Chronic Renal Disease Patients
An observational study of Chronic Kidney Disease, run by National Taiwan University Hospital.
Trial summary
Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of authors consider urinary kallikrein is a marker of nephropathy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2006
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- During June 2004 and June 2005 who participate the clinical study "Efficacy of Pentoxifylline on Chronic Kidney Disease" (ClinicalTrials.gov Identifier: NCT00155246)and sign the informed consent.
- Chronic kidney disease history > 3 months, Serum creatinine: 1.1~6.0 mg/dl in female. 1.3~6.2 mg/dl in male.
- Initial Random urine protein (mg/dl) /creatinine (mg/dl) ratio > 0.5
Who cannot join
- History of allergy to pentoxifylline;
- females are nursing or pregnant;
- Obstructive uropathy;
- Unable to stop chronic immunosuppressive therapy, NSAID;
- Congestive heart failure (New York Heart Association functional class III or IV);
- Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form;
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- Cerebral hemorrhage within the past 6 months prior to signing the informed consent form;
- Retinal hemorrhage within the past 6 months prior to signing the informed consent form;
- Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma);
- Severe uncontrolled hypertension with SBP > 220 mmHg and/or DBP > 115 mmHg;
- Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 2 times the upper limit of the normal range;
- Biliary obstructive disorders (e.g. cholestasis);
- Active malignancy
About this study
Official title: The Correlation of Urine Tissue Kallikrein Protein Level With Cytokines, Degree of Proteinuria and Renal Function Deterioration in Chronic Renal Disease Patients After Angiotensin II Receptor Blocking
Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of authors consider urinary kallikrein is a marker of nephropathy. To evaluate the possible role of kallikrein kinin system in chronic kidney disease, we conduct a retrospective longitudinal observation study. Patients who participating in the "Efficacy of Pentoxifylline on Chronic Kidney Disease" study are included in the study. The morning spot urinary kallikrein and cytokines are measured at the time point of 0 and 12 month in addition to clinical parameters. The correlation of urinary kallikrein and cytokine concentration will be evaluated. Using multiple regression model, the relationship of urinary kallikrein excretion with degree of proteinuria, creatinine clearance and other clinical parameter will also be evaluated.
- Conditions
- Chronic Kidney Disease
- Keywords
- Kallikrein, Cytokines, Proteinuria, Renal function, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startOct 2006
- Study completionOct 2006
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 National Taiwan University 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
- Natural history
- Time perspective
- Retrospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Chih Chiang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395005
- Sponsor's protocol ID
- 9561709146
- Status last verified
- Oct 2006
- First submitted
- 31 Oct 2006
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Urine Tissue Kallikrein Protein Level With Cytokines, Degree of Proteinuria and Renal Function Deterioration in Chronic Renal Disease Patients After Angiotensin II Receptor Blocking
- ClinicalTrials.gov ID
- NCT00395005
- Acronym / sponsor ID
- 9561709146
- Conditions
- Chronic Kidney Disease
- Keywords
- Kallikrein, Cytokines, Proteinuria, Renal function, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Oct 2006
- First posted
- 2 Nov 2006 (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.
Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of authors consider urinary kallikrein is a marker of nephropathy. To evaluate the possible role of kallikrein kinin system in chronic kidney disease, we conduct a retrospective longitudinal observation study. Patients who participating in the "Efficacy of Pentoxifylline on Chronic Kidney Disease" study are included in the study. The morning spot urinary kallikrein and cytokines are measured at the time point of 0 and 12 month in addition to clinical parameters. The correlation of urinary kallikrein and cytokine concentration will be evaluated. Using multiple regression model, the relationship of urinary kallikrein excretion with degree of proteinuria, creatinine clearance and other clinical parameter will also be evaluated.
Study design
- Observational model
- Natural history
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- During June 2004 and June 2005 who participate the clinical study "Efficacy of Pentoxifylline on Chronic Kidney Disease" (ClinicalTrials.gov Identifier: NCT00155246)and sign the informed consent.
- Chronic kidney disease history > 3 months, Serum creatinine: 1.1~6.0 mg/dl in female. 1.3~6.2 mg/dl in male.
- Initial Random urine protein (mg/dl) /creatinine (mg/dl) ratio > 0.5
Key exclusion criteria (13 listed)
- History of allergy to pentoxifylline;
- females are nursing or pregnant;
- Obstructive uropathy;
- Unable to stop chronic immunosuppressive therapy, NSAID;
- Congestive heart failure (New York Heart Association functional class III or IV);
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
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 23 Mar 2007.
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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.
Wen-Chih Chiang, MD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by National Taiwan University Hospital.
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 13 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 23 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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 23 Mar 2007.