Study of the Link Between Complement Activation and IgA Nephropathy Severity

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Primary outcome measure(s)

• Incidence of a severe form of IgA nephropathy — At 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 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.
• 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 sites (1)

More University Hospital, Strasbourg, France trials in France