Early Change in Proteinuria as a Surrogate Endpoint in Studies of IgA Nephropathy: An Updated Patient-Level Meta-analysis and Discussion of Appropriate Methodology
The FDA and EMA have accepted proteinuria as a valid surrogate outcome for use in clinical trials of new interventions for the treatment of IgA nephropathy, and the present analysis provides further indications that interventions that reduce proteinuria in a short-term trial are likely to improve kidney outcomes over the long term.
Authors
- Nicolas Maillard (ORCID: https://orcid.org/0000-0002-3073-7252)
- Barnaby Hunt (ORCID: https://orcid.org/0000-0001-5420-279X)
- Alex Mercer (ORCID: https://orcid.org/0009-0006-5279-1416)
- Khalil El Karoui (ORCID: https://orcid.org/0000-0002-2978-6698)
- Kevin J. Carroll
Institutions
- Université Claude Bernard Lyon 1 (FR)
- Inserm (FR)
- Sorbonne Université (FR)
- Centre de Recherche en Neurosciences de Lyon (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Central Statistics Office (IE)
- Paris Cardiovascular Research Center (FR)
- Department of Health (IE)
- Centre Hospitalier Universitaire de Saint-Étienne (FR)
- Centre International de Recherche en Infectiologie (FR)
- Hôpital Tenon (FR)
- Maladies rénales fréquentes et rares : des mécanismes moléculaires à la médecine personnalisée
Publication Details
- Journal
- Advances in Therapy
- Published
- 2025-11-12
- DOI
- https://doi.org/10.1007/s12325-025-03402-5
- Primary Topic
- Renal Diseases and Glomerulopathies
- Type
- article
- Field-Weighted Citation Impact
- 0.00