NKF-FDA Workshop Articles

Articles arising from a workshop cosponsored by the National Kidney Foundation and the US Food and Drug Administration, held December 2-3, 2012, in Baltimore, Maryland.


Special Report
GFR Decline as an End Point for Clinical Trials in CKD: A Scientific Workshop Sponsored by the National Kidney Foundation and the US Food and Drug AdministrationAndrew S. Levey, Lesley A. Inker, Kunihiro Matsushita, Tom Greene, Kerry Willis, Edmund Lewis, Dick de Zeeuw, Alfred K. Cheung, and Josef Coresh

Editorials
GFR Decline as an End Point in Trials of CKD: A Viewpoint from the FDA Aliza Thompson, John Lawrence, and Norman Stockbridge

GFR Decline as an End Point for Clinical Trials in CKD: A View From Europe Peter G.M. Mol, Romaldas Maciulaitis, and Thorsten Vetter

GFR Decline as an Alternative End Point in Clinical Trials to Prevent ESRD: Are We Increasing Treatment Uncertainty for the Sake of Feasibility? Jessica M. Sontrop, Ahmed Al-Jaishi, and Amit X. Garg

In the Literature
Surrogate Outcomes for ESRD Risk: The Case for a 30% Reduction in Estimated GFR Over 2 YearsJessica M. Sontrop, Matthew A. Weir, and Amit X. Garg

Original Investigations
GFR Decline as an Alternative End Point to Kidney Failure in Clinical Trials: A Meta-analysis of Treatment Effects From 37 Randomized Trials Lesley A. Inker, Hiddo J. Lambers Heerspink, Hasi Mondal, Christopher H. Schmid, Hocine Tighiouart, Farzad Noubary, Josef CoreshTom Greene, and Andrew S. Levey

GFR Decline and Subsequent Risk of Established Kidney Outcomes: A Meta-analysis of 37 Randomized Controlled Trials Hiddo J. Lambers Heerspink, Hocine Tighiouart, Yingying Sang, Shoshana Ballew, Hasi Mondal, Kunihiro Matsushita, Josef Coresh, Andrew S. Levey, and Lesley A. Inker

Utility and Validity of Estimated GFR–Based Surrogate Time-to-Event End Points in CKD: A Simulation Study Tom Greene, Chia-Chen Teng, Lesley A. Inker, Andrew Redd, Jian Ying, Mark Woodward, Josef Coresh, and Andrew S. Levey

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