Study of the Link Between Complement Activation and IgA Nephropathy Severity

Recruiting

• Conditions: IgA Nephropathy Severity in Kidney Transplantation

• Registration Number: NCT05234463
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

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 Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-05-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of a severe form of IgA nephropathy	1 year after inclusion	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).

Trial Locations

Locations (1)

Service de néphrologie; 🇫🇷 Strasbourg, France