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

March 22, 2007 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Natural History
  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Wen-Chih Chiang, MD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

November 1, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

March 23, 2007

Last Update Submitted That Met QC Criteria

March 22, 2007

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9561709146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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