Surrogate endpoints in clinical trials of chronic kidney disease progression

Schievink, Bauke; Mol, Peter G. M.; Heerspink, Hiddo J L

doi:10.1097/mnh.0000000000000159

Cited by 7 publications

(9 citation statements)

References 47 publications

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“…The sample used in the study is similar to the nondialysis CKD populations described by other authors ( 10 – 14 ), particularly the average age, which was close to 70 years. In one-third of CKD patients, the etiology is DM.…”

Section: Discussionmentioning

confidence: 61%

“…The use of surrogate endpoints to evaluate CKD progression in randomized clinical trials has been justified by the possibility of reducing sample sizes and follow-up time. A surrogate endpoint is also expected to predict a treatment's clinical benefit, damage, or lack thereof, especially at shorter time intervals, which adds important complexity to the data analysis, as seen below (10)(11)(12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

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A proposal to analyze the progression of non-dialytic chronic kidney disease by surrogate endpoints: introducing parametric survival models

2023

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IntroductionChronic kidney disease (CDK) progression studies increasingly use surrogate endpoints based on the estimated glomerular filtration rate. The clinical characteristics of these endpoints bring new challenges in comparing groups of patients, as traditional Cox models may lead to biased estimates mainly because they do not assume a hazard function.ObjectiveThis study proposes the use of parametric survival analysis models with the three most commonly used endpoints in nephrology based on a case study. Estimated glomerular filtration rate (eGFR) decay > 5 mL/year, eGFR decline > 30%, and change in CKD stage were evaluated.MethodThe case study is a 5-year retrospective cohort study that enrolled 778 patients in the predialysis stage. Exponential, Weibull, Gompertz, lognormal, and logistic models were compared, and proportional hazard and accelerated failure time (AFT) models were evaluated.ResultsThe endpoints had quite different hazard functions, demonstrating the importance of choosing appropriate models for each. AFT models were more suitable for the clinical interpretation of the effects of covariates on these endpoints.ConclusionSurrogate endpoints have different hazard distributions over time, which is already recognized by nephrologists. More flexible analysis techniques that capture these relevant clinical characteristics in decision-making should be encouraged and disseminated in nephrology research.

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Section: Discussionmentioning

confidence: 61%

Section: Introductionmentioning

confidence: 99%

A proposal to analyze the progression of non-dialytic chronic kidney disease by surrogate endpoints: introducing parametric survival models

2023

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“…Although prevention of or reduction in the risk of end-stage kidney disease (ESKD) is an accepted clinically meaningful end point of CKD treatment, several surrogate end points have been developed to facilitate clinical trials ( 36 ). Levey et al.…”

Section: Treatment Goals: Surrogate and Clinically Meaningful End Pointsmentioning

confidence: 99%

Perspectives on Chronic Kidney Disease With Type 2 Diabetes and Risk Management: Practical Viewpoints and a Paradigm Shift Using a Pillar Approach

Morales¹,

Dagogo‐Jack

Fonseca

et al. 2023

Clinical Diabetes

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“…This observation led to the development of some diagnostic approaches for "multimarker" analysis so that the specificity and sensitivity of detection can be increased and/or improved. [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]…”

Section: Current Status Of Dn Biomarkersmentioning

confidence: 99%

Mini‒review: clinical and molecular markers in early diabetic nephropathy

Reda

Amin

2018

MOJDDT

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Diabetes mellitus (DM) is the sixth leading cause of death worldwide because of its complications. One of these deadly complications is diabetic nephropathy, the leading cause of end-stage renal disease in the western world. Despite the worldwide acceptance to use albumin-to-creatinine (A/C) ratio and estimated glomerular filtration rate (eGFR) in clinical settings, there is no trustable and valid biochemical marker that can sensitively detect early stages of diabetic nephropathy. Therefore the early detection of the deterioration in kidney function and the changes in kidney structure before the albumin level becomes significantly high in urine is very important for patient's life. The aim of this review is to summarize some novel clinical and molecular markers being investigated as potential candidates to fill in the gap.

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Surrogate endpoints in clinical trials of chronic kidney disease progression

Abstract: Given that drugs affect multiple renal risk markers, risk scores that integrate these effects are a promising alternative to using eGFR decline or albuminuria. Proper validation is required before these risk scores can be implemented.

Cited by 7 publications

References 47 publications

A proposal to analyze the progression of non-dialytic chronic kidney disease by surrogate endpoints: introducing parametric survival models

A proposal to analyze the progression of non-dialytic chronic kidney disease by surrogate endpoints: introducing parametric survival models

Perspectives on Chronic Kidney Disease With Type 2 Diabetes and Risk Management: Practical Viewpoints and a Paradigm Shift Using a Pillar Approach

Mini‒review: clinical and molecular markers in early diabetic nephropathy

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