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Correlation of Urinary Kallikrein With Cytokines, Proteinuria and Renal Function in Chronic Renal Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395005
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : March 23, 2007
Information provided by:
National Taiwan University Hospital

Brief 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. 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.

Condition or disease
Chronic Kidney Disease

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Study Type : Observational
Enrollment : 50 participants
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
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
Study Start Date : October 2006
Study Completion Date : October 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • During June 2004 and June 2005 who participate the clinical study "Efficacy of Pentoxifylline on Chronic Kidney Disease" ( 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

Exclusion Criteria:

  • 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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395005

Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Wen-Chih Chiang, MD National Taiwan University Hospital

Layout table for additonal information Identifier: NCT00395005     History of Changes
Other Study ID Numbers: 9561709146
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: March 23, 2007
Last Verified: October 2006
Keywords provided by National Taiwan University Hospital:
Renal function
Chronic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs