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

This study has been completed.

First Received: October 31, 2006 Last Updated: March 22, 2007 History of Changes

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

MedlinePlus related topics: Urine and Urination

Drug Information available for: Kallidinogenase

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

No publications provided

Study ID Numbers:	9561709146
Study First Received:	October 31, 2006
Last Updated:	March 22, 2007
ClinicalTrials.gov Identifier:	NCT00395005 History of Changes
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:

Renal Insufficiency
Coagulants
Urination Disorders
Physiological Effects of Drugs
Hematologic Agents
Kidney Failure, Chronic
Reproductive Control Agents
Fertility Agents, Male
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Proteinuria
Urologic Diseases
Kallikreins
Renal Insufficiency, Chronic
Therapeutic Uses
Fertility Agents
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009