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<p>Nephrology has seen a&#xa0;surge of clinical trials with significant investment by industry to improve patient care in several areas, including diabetes and chronic kidney diseases (CKD) and rare diseases, such as immunoglobulin A (IgA) nephropathy (IgAN). The reason for these investments is in part that nephrologists, agency representatives (especially of the U.S. Food and Drug Administration, FDA) and companies have defined new outcomes of clinical trials. These enable the design and conduct of such clinical trials in a&#xa0;more economical way; i.e., a&#xa0;more manageable number of trial participants and a shorter duration of follow-up. In consequence, the field of nephrology has evolved into a&#xa0;discipline where the speed of development and approval of new interventions is rapidly growing. This article provides an overview of issues with trials conducted in nephrology in the past and outline new surrogate endpoints that have recently been implemented in several fields of nephrology.</p>

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Regulatorik: neue Endpunkte in chronische Nierenerkrankungs(CKD)-Studien

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月21日

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  • Andreas Kronbichler,
  • Sara H. Ksiazek

摘要

Nephrology has seen a surge of clinical trials with significant investment by industry to improve patient care in several areas, including diabetes and chronic kidney diseases (CKD) and rare diseases, such as immunoglobulin A (IgA) nephropathy (IgAN). The reason for these investments is in part that nephrologists, agency representatives (especially of the U.S. Food and Drug Administration, FDA) and companies have defined new outcomes of clinical trials. These enable the design and conduct of such clinical trials in a more economical way; i.e., a more manageable number of trial participants and a shorter duration of follow-up. In consequence, the field of nephrology has evolved into a discipline where the speed of development and approval of new interventions is rapidly growing. This article provides an overview of issues with trials conducted in nephrology in the past and outline new surrogate endpoints that have recently been implemented in several fields of nephrology.