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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395005
• Other study ID #: 9561709146
• Status: Completed
• Phase: N/A
• First received: October 31, 2006
• Last updated: March 22, 2007
• Start date: October 2006
• Est. completion date: October 2006

Study information

• Verified date: October 2006
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Proteinuria
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital