- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02529722
Biomarkers for the Progression of IgA Nephropathy
Histological and Clinical Biomarkers to Predict the Progression of IgA Nephropathy
Study Overview
Status
Conditions
Detailed Description
IgA nephropathy is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. Clinical course varies from long term stable renal functions with minimal proteinuria and microscopic hematuria to rapidly progressive glomerulonephritis with crescents on renal biopsy which progresses to end stage renal disease in a very short time.
In current practice the diagnosis is made with renal biopsy. A less invasive procedure for diagnosis is not present and no serum biomarkers for clinical follow-up, treatment response and prognosis are available. For that reason follow-up of the disease is enabled with indirect markers of renal function like proteinuria, serum creatinine and glomerular filtration rate. These markers are not specific for IgA nephropathy. The lack of disease specific markers hinders the standardization of patient follow-up and treatment. Development of specific and sensitive, repeatable, histopathological and clinical markers for diagnosis, follow up and treatment response in IgA nephropathy the most prevalent primary glomerular disease affecting many patients worldwide will offer prospects of diagnosis and improved prognostication.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34093
- Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with biopsy-proven IgA nephropathy (defined by standard criteria)
- Patients at all ages will be included regardless of treatment given
- A renal biopsy available for reviewing must include 8 or more glomeruli.
- At least 3 measurements of blood pressure, serum creatinine and proteinuria have to be performed.
- The first measurement should be within 3 months of the date of renal biopsy and the last at the end of the follow-up.
Patients must comply with the following criteria
- have a follow-up longer than 1 year
- or having progressed to end-stage renal disease regardless of the duration of follow-up.
- Patients who have received antihypertensive or immunosuppressive medication will be included as well.
Exclusion Criteria:
- Diabetes at the time of first kidney biopsy.
- Solid organ (other than kidney) or bone marrow transplant at the time of biopsy.
- Other pre-existing parenchymal kidney disease on first kidney biopsy, determined by the pathology examination.
- Diagnosis of any of the following diseases from the time of biopsy to the time of enrollment: Systemic lupus erythematosus, HIV infection, active malignancy, except for non-melanoma skin cancer, active hepatitis B or C infection, defined as positive viral load
- Patients with life expectancy < 6 months
- Patients who are unwilling or unable to consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression to end stage renal disease or two-fold increase in serum creatinine level as compared to baseline
Time Frame: 36 months
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resistance of proteinuria
Time Frame: 36 months
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Resistance of proteinuria defined as no improvement in the daily proteinuria levels or >1 g/24 hr proteinuria
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36 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2907 (Other Identifier: Portland VA Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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