Kidney failure is a clinical and patient-centered outcome of interest for monitoring and investigating the progression of chronic kidney disease (CKD). A recent Kidney Disease: Improving Global Outcomes (KDIGO) Consensus Conference emphasized the importance of explicitly defining kidney failure in terms of kidney function, duration, symptoms, and/or treatment. The International Society of Nephrology thus proposed that in the setting of clinical trials, kidney failure outcomes be comprised of a composite including kidney transplantation, maintenance dialysis, and death from kidney failure. In observational and clinical settings, understanding and identifying patients with CKD at high risk of kidney failure can accelerate the interpretation of data and treatment decisions, for example, to mitigate CKD progression or prepare patients for kidney replacement therapy (KRT). Surrogate end points are often needed in clinical research because a small sample size or short follow-up time implies a potentially low number of KRT events.

The International Society of Nephrology consensus suggested that a sustained low glomerular filtration rate (GFR) and a sustained percent decline in GFR could be incorporated into a kidney failure outcome, as the former is concordant with KDIGO guideline definitions for kidney failure and the latter has been extensively studied as an acceptable surrogate for kidney failure by researchers and regulatory agencies. These surrogate end points are advantageous not only in clinical trials but also in observational studies because kidney disease progression can be slow in some patients, even among those with advanced CKD and especially among those with CKD etiologies such as glomerulonephritis, polycystic kidney disease, or interstitial disease, who may be enrolled in clinical studies at higher estimated GFRs (eGFRs) or have slower progression. In clinical care, the eGFR-based surrogate end points can be useful for monitoring patients before they reach kidney failure. New treatment strategies and targets from recent trials—for example, blood pressure control in SPRINT, SGLT2i in CREDENCE, and finerinone in FIDELIO-DKD—have triggered recent changes in practice guidelines and will soon be introduced in clinical practice. Demonstrating earlier treatment effects on validated surrogate end points in the real world, especially among high-risk populations (eg, patients with CKD with low eGFR and high albuminuria), would allow for quicker analysis of practice patterns related to best outcomes and the earlier introduction of therapies that could prevent or postpone KRT. If proven efficient, this harmonized application of surrogates across clinical research applications may have a strong impact in improving kidney failure outcomes for patients.

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Mishita
Jornal co-ordinator
Journal of Clinical & Experimental Nephrology