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

This study has been completed.

Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00395005
  Purpose

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
Chronic Kidney Disease

ChemIDplus related topics:   Kallidinogenase    Angiotensin II    Angiotensin II, ile(5)-   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Convenience Sample, Retrospective 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

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment:   50
Study Start Date:   October 2006
Estimated Study Completion Date:   October 2006

  Eligibility
Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395005

Sponsors and Collaborators
National Taiwan University Hospital

Investigators
Principal Investigator:     Wen-Chih Chiang, MD     National Taiwan University Hospital    
  More Information

Study ID Numbers:   9561709146
First Received:   October 31, 2006
Last Updated:   March 22, 2007
ClinicalTrials.gov Identifier:   NCT00395005
Health Authority:   Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Kallikrein  
Cytokines  
Proteinuria  
Renal function  
Chronic kidney disease  

Study placed in the following topic categories:
Signs and Symptoms
Renal Insufficiency
Proteinuria
Kallikreins
Urologic Diseases
Urination Disorders
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Angiotensin II
Kidney Failure

Additional relevant MeSH terms:
Urological Manifestations
Coagulants
Therapeutic Uses
Physiological Effects of Drugs
Fertility Agents
Hematologic Agents
Reproductive Control Agents
Fertility Agents, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




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