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• W2741750893 abstract "Background: There is interest in surrogate end points for clinical trials of chronic kidney disease progression because currently established end points—end-stage renal disease (ESRD) and doubling of serum creatinine level—are late events, requiring large clinical trials with long follow-up. Doubling of serum creatinine level is equivalent to a 57% decline in estimated glomerular filtration rate (eGFR). We evaluated type 1 error and required sample size for clinical trials using surrogate end points based on lesser eGFR declines. Study Design: Simulation study. Setting & Participants: Simulations evaluating 3,060 scenarios representative of 19 treatment comparisons in 13 chronic kidney disease clinical trials. Index Tests: Surrogate end points defined as composite end points based on ESRD and either 30% or 40% eGFR declines. Reference Test: Clinical outcome (ESRD) for type 1 error. Established end point (composite of ESRD and 57% eGFR decline) for required sample size. Results: Use of the 40% versus 57% eGFR decline end point consistently led to a reduction in sample size . 20% while maintaining risk for type 1 error , 10% in the presence of a small acute effect (,1.25 mL/min/ 1.73 m 2 ) for: (1) 2-, 3-, or 5-year trials with a high mean baseline eGFR (67.5 mL/min/1.73 m 2 ), and (2) 2-year trials with an intermediate mean baseline eGFR (42.5 mL/min/1.73 m 2 ). Use of the 30% versus the 40% eGFR decline end point often led to moderately larger reductions in sample size in the absence of an acute effect, but not in the presence of acute effects. Limitations: The complexity of eGFR trajectories prevented evaluation of all scenarios for clinical trials. Conclusions: Use of end points based on 30% or 40% eGFR declines is an appropriate strategy to reduce sample size in certain situations. However, risk for type 1 error is increased in the presence of acute effects, particularly for 30% eGFR declines. The decision to use these end points should be made after thorough evaluation of their expected performance under the conditions of specific clinical trials. Am J Kidney Dis. 64(6):867-879. a 2014 by the National Kidney Foundation, Inc." @default.
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• W2741750893 date "2014-01-01" @default.
• W2741750893 modified "2023-10-07" @default.
• W2741750893 title "Original Investigation Utility and Validity of Estimated GFR-Based Surrogate Time-to-Event End Points in CKD: A Simulation Study" @default.
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• W2741750893 hasPublicationYear "2014" @default.
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