Study of the Link Between Complement Activation and IgA Nephropathy Severity

Last updated: August 1, 2025
Sponsor: University Hospital, Strasbourg, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glomerulonephritis

Treatment

IgAN patients

Clinical Study ID

NCT05234463
8361
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Active or recent infectious or inflammatory syndrome (<2 months), recent vaccination (<2 months), ongoing acute humoral rejection treatment, treatment with plasmaexchanges (<2 months), current treatment with complement inhibitors

  • Impossibility of giving informed information (emergency situation, difficulties inunderstanding, etc.)

  • Subject under safeguard of justice, guardianship or curatorship

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: IgAN patients
Phase:
Study Start date:
May 09, 2022
Estimated Completion Date:
May 01, 2027

Study 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

Connect with a study center

  • Service de néphrologie

    Strasbourg,
    France

    Active - Recruiting

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