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

NCT ID: NCT02493101

Last Updated: 2015-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lupus Nephritis IgA Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chronic kidney disease

Patients with lupus nephritis and IgA nephropathy

No interventions assigned to this group

Control

Healthy controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thailand Research Fund

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRBRTA1168/2556

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Autoimmune Hepatitis Study
NCT00286663 TERMINATED