NCT02529722

Biomarkers for the Progression of IgA Nephropathy

Histological and Clinical Biomarkers to Predict the Progression of IgA Nephropathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per million age-related population in adults and 3-5/new cases/year/per million age-related population in children and progresses to need of renal replacement treatment in 5-15% at 10 years and in about 20% at 20 years. The variability of the clinical course anticipates different treatment options. There is an absolute need of validated biomarkers to predict risk of progression and indication for treatment at early stages, when lesions can be reversible. This study aimed to evaluate IgAN progression and its histological and clinical correlates.

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.

Conditions

• IgA Nephropathy
• Glomerular Diseases

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2015-08-20
• Last updated: 2015-08-20

Locations

1 site across 1 country: Turkey (Türkiye)