NCT00395005

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
Last Updated

March 23, 2007

Status Verified

October 1, 2006

First QC Date

October 31, 2006

Last Update Submit

March 22, 2007

Conditions

Keywords

KallikreinCytokinesProteinuriaRenal functionChronic kidney disease

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuria

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Study Officials

  • Wen-Chih Chiang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 2, 2006

Study Start

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 23, 2007

Record last verified: 2006-10