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ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.
The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.
IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgAN patients | Other | Adult patients Histologically proven diagnosis of IgA nephropathy Primary and secondary forms of the disease With or without kidney transplantation history Regardless of kidney/graft function Patients followed in the Nephrology Department of Strasbourg University Hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a severe form of IgA nephropathy | Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the incidence of end stage kidney disease, iii) the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score). Infra-clinical complement activation is defined as a sC5b-9 > 300ng/mL in plasma or a positive ex vivo complement activation functional test on endothelial cells. | At inclusion |
| Incidence of a severe form of IgA nephropathy | Occurrence of a severe form of IgA nephropathy, with at least one of the following severity criteria: i) a rapid decline in estimated glomerular filtration rate the presence of malignant hypertension or thrombotic microangiopathy features, iv) histological endo and/or extra capillary proliferation (E1 and/or C1 according to Oxford 2016 MEST-C score). | 1 year after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with a histologically proven diagnosis of IgA nephropathy, with or without kidney transplantation history followed in the Nephrology Department of Strasbourg University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Ohlmann- Caillard, MD | Contact | 03.88.11.67.68 | sophie.ohlmann@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de néphrologie | Recruiting | Strasbourg | France |
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