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Completed

NCT Number: NCT02493101

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Urine periostin level in lupus nephritis and IgA nephropathy patients compared with healthy controls

    Time frame: 2 years

Secondary outcomes

  1. Correlation of urine periostin level in lupus nephritis and IgA nephropathy patients and other variables

    Time frame: 2 years

  2. The best cutoff value of urine periostin level for distinguishing patients from healthy controls

    Time frame: 2 years

  3. The variables that involved in urine periostin detection in lupus nephritis and IgA nephropathy patients

    Time frame: 2 years

  4. Periostin staining in kidney tissue from lupus nephritis and IgA nephropathy patients

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Thailand Research Fund

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2015
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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