Study of the Link Between Complement Activation and IgA Nephropathy Severity (ICONE)

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.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy Severity in Kidney Transplantation
• Intervention / Treatment: Other: IgAN patients

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

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Sophie Ohlmann- Caillard, MD; Phone Number: 03.88.11.67.68; Email: sophie.ohlmann@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • Service de néphrologie
    • Contact: Sophie Caillard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: 8361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No