The Correlation of Periostin and Renal Pathology in Chronic Kidney Disease Patients

July 8, 2015 updated by: Chulalongkorn University

Potential of Periostin as a Tissue and Urinary Biomarker in Lupus Nephritis and IgA Nephropathy Patients

The purpose of this study is to determine the location of periostin and urine periostin level in patients with lupus nephritis and IgA nephropathy.

Study Overview

Status

Completed

Conditions

Detailed Description

Total of 50 lupus nephritis and IgA nephropathy patients who met the inclusion criteria were included in this study. The information sheet and informed consent will be obtained before collecting the patient's data. All patients were interviewed for collecting demographic data and laboratory testing were reviewed from patient's record. Kidney tissue and urine sample were collected at the biopsy date from patients.Kidney tissue were stained with hematoxylin and eosin (H&E), Masson's trichrome solution and immunohistochemistry for periostin. The location of periostin staining in kidney tissue were assessed by renal pathologist.

The total of 50 urine samples from patients and 50 urine samples from healthy controls were measured for periostin level by enzyme-linked immunosorbent assay. The Mann-Whitney rank-sum test was used for comparing urine periostin level between patients and healthy controls and also other variables between patients with urine periostin detection and without urine periostin detection. Spearman correlation coefficients were used test correlations between urine periostin level in patients and other variables. Receiver operating characteristic curves was generated to calculate the area under the curve and find the best cutoff value of urine periostin level for distinguishing patients from healthy controls. P-values < 0.05 were considered statistically significant.

Study Type

Observational

Enrollment (Actual)

100

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients visiting at the Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand

Description

Inclusion Criteria:

  • aged over 18 years
  • at least three glomeruli obtained at biopsy

Exclusion Criteria:

  • Patients with urinary tract obstruction
  • Patients with urinary tract infection
  • Patients with kidney transplant
  • Patients with cancer diseases
  • Patients with asthma
  • Patients with advanced heart disease
  • Pregnancy and lactation

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

Cohorts and Interventions

Group / Cohort
Control
Healthy controls
Chronic kidney disease
Patients with lupus nephritis and IgA nephropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urine periostin level in lupus nephritis and IgA nephropathy patients compared with healthy controls
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of urine periostin level in lupus nephritis and IgA nephropathy patients and other variables
Time Frame: 2 years
2 years
The best cutoff value of urine periostin level for distinguishing patients from healthy controls
Time Frame: 2 years
2 years
The variables that involved in urine periostin detection in lupus nephritis and IgA nephropathy patients
Time Frame: 2 years
2 years
Periostin staining in kidney tissue from lupus nephritis and IgA nephropathy patients
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Collaborators

Thailand Research Fund

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

April 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBRTA1168/2556

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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