Clinical trial NCT02493101: The Correlation of Periostin and Renal Pathology in Chronic Kidney Disease Patients
Official title: Potential of Periostin as a Tissue and Urinary Biomarker in Lupus Nephritis and IgA Nephropathy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Nephritis
IgA Nephropathy
Keywords: Periostin staining
Urine periostin level
Lupus nephritis
IgA nephropathy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2015-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting at the Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urine periostin level in lupus nephritis and IgA nephropathy patients compared with healthy controls
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of urine periostin level in lupus nephritis and IgA nephropathy patients and other variables
timeFrame: 2 years
measure: The best cutoff value of urine periostin level for distinguishing patients from healthy controls
timeFrame: 2 years
measure: The variables that involved in urine periostin detection in lupus nephritis and IgA nephropathy patients
timeFrame: 2 years
measure: Periostin staining in kidney tissue from lupus nephritis and IgA nephropathy patients
timeFrame: 2 years
Other outcomes:
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