Lupus NephritisNCT02493101
The Correlation of Periostin and Renal Pathology in Chronic Kidney Disease Patients
An observational study of Lupus Nephritis and IgA Nephropathy, run by Chulalongkorn University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis, IgA Nephropathy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting at the Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand
Who may be able to join
- aged over 18 years
- at least three glomeruli obtained at biopsy
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Lupus Nephritis, IgA Nephropathy
- Keywords
- Periostin staining, Urine periostin level, Lupus nephritis, IgA nephropathy
- Medical subject headings
- Lupus Nephritis, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Patients with lupus nephritis and IgA nephropathy | |
| Control | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine periostin level in lupus nephritis and IgA nephropathy patients compared with healthy controls
Measured: 2 years
Secondary outcomes (4)
Correlation of urine periostin level in lupus nephritis and IgA nephropathy patients and other variables
Measured: 2 years
The best cutoff value of urine periostin level for distinguishing patients from healthy controls
Measured: 2 years
The variables that involved in urine periostin detection in lupus nephritis and IgA nephropathy patients
Measured: 2 years
Periostin staining in kidney tissue from lupus nephritis and IgA nephropathy patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493101
- Sponsor's protocol ID
- IRBRTA1168/2556
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Periostin as a Tissue and Urinary Biomarker in Lupus Nephritis and IgA Nephropathy Patients
- ClinicalTrials.gov ID
- NCT02493101
- Acronym / sponsor ID
- IRBRTA1168/2556
- Conditions
- Lupus Nephritis, IgA Nephropathy
- Keywords
- Periostin staining, Urine periostin level, Lupus nephritis, IgA nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | –Patients with lupus nephritis and IgA nephropathy |
| Control | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting at the Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand
Key inclusion criteria (2 listed)
- aged over 18 years
- at least three glomeruli obtained at biopsy
Key exclusion criteria (7 listed)
- Patients with urinary tract obstruction
- Patients with urinary tract infection
- Patients with kidney transplant
- Patients with cancer diseases
- Patients with asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urine periostin level in lupus nephritis and IgA nephropathy patients compared with healthy controls
Time frame: 2 years
4 secondary outcomes
Correlation of urine periostin level in lupus nephritis and IgA nephropathy patients and other variables
Time frame: 2 years
The best cutoff value of urine periostin level for distinguishing patients from healthy controls
Time frame: 2 years
The variables that involved in urine periostin detection in lupus nephritis and IgA nephropathy patients
Time frame: 2 years
Periostin staining in kidney tissue from lupus nephritis and IgA nephropathy patients
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis and IgA Nephropathy, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine periostin level in lupus nephritis and IgA nephropathy patients compared with healthy controls (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.