Study of the Link Between Complement Activation and IgA Nephropathy Severity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IgAN patients.
- Who it may be relevant to
- Registry conditions: IgA Nephropathy Severity in Kidney Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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
Interventions
- Other IgAN patients
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.
Primary outcome measures
- Incidence of a severe form of IgA nephropathy [Time frame: At inclusion]
- Incidence of a severe form of IgA nephropathy [Time frame: 1 year after inclusion]
Eligibility criteria
Inclusion criteria
- Adult patients, male or female, with a biopsy proven IgA nephropathy.
- Primitive and secondary forms can be included
- Regardless of the date of diagnosis and the level of kidney function
- With or without past of kidney transplantation
- Followed in the Nephrology Department, Strasbourg University Hospital
- Signed informed consent
Exclusion criteria
- Active or recent infectious or inflammatory syndrome (<2 months), recent vaccination (<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (<2 months), current treatment with complement inhibitors
- Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
- Subject under safeguard of justice, guardianship or curatorship
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Service de néphrologie — Strasbourg
Publications
- Duval A, Maillard N, Morin M, El Sissy C, Vieira-Martins P, Durand A, Roquigny J, Lecerf M, Chauvet S, Olagne J, Moulin B, Roumenina L, Limou S, Mariat C, Caillard S, Fremeaux-Bacchi V. Association of Complement Genetics with Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1207-1221. doi: 10.2215/CJN.0000001062. Epub 2026 May 15. PMID 42138996
Identifiers
NCT: NCT05234463 · 8361