NCT02493101

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

July 6, 2015

Last Update Submit

July 8, 2015

Conditions

Lupus NephritisIgA Nephropathy

Keywords

Periostin stainingUrine periostin levelLupus nephritisIgA nephropathy

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (4)

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

    2 years

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

    2 years

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

    2 years

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

    2 years

Study Arms (2)

Chronic kidney disease

Patients with lupus nephritis and IgA nephropathy

Control

Healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and kidney tissue

MeSH Terms

Conditions

Lupus NephritisGlomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 9, 2015

Study Start

April 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 9, 2015

Record last verified: 2015-07