{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Heerspink HJL"],"funding":["NCATS NIH HHS","Medical Research Council"],"pagination":["955-968"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10278784"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["34(6)"],"pubmed_abstract":["<h4>Significance statement</h4>Changes in albuminuria and GFR slope are individually used as surrogate end points in clinical trials of CKD progression, and studies have demonstrated that each is associated with treatment effects on clinical end points. In this study, the authors sought to develop a conceptual framework that combines both surrogate end points to better predict treatment effects on clinical end points in Phase 2 trials. The results demonstrate that information from the combined treatment effects on albuminuria and GFR slope improves the prediction of treatment effects on the clinical end point for Phase 2 trials with sample sizes between 100 and 200 patients and duration of follow-up ranging from 1 to 2 years. These findings may help inform design of clinical trials for int"],"journal":["Journal of the American Society of Nephrology : JASN"],"pubmed_title":["Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD."],"pmcid":["PMC10278784"],"funding_grant_id":["MR/N006178/1","UL1 TR002538"],"pubmed_authors":["Greene T","Pohl M","Tighiouart H","Pozzi C","Keane W","Praga M","Hunsicker LG","Lewis JB","van Essen GG","Ito S","Brosnahan G","Malfait T","Wanner C","Szeto CC","Gherardi G","Xie D","Collier WH","von Eynatten M","Cavero T","Kobayashi F","Haaland B","Lesti MD","Floege J","Maschio G","Donadio J","Trujillo H","Chan TM","Dwyer J","Gutierrez E","Imai E","Kam-Tao Li P","Vanacker A","Beck G","Makino H","Andrulli S","Chow KM","Leung CB","Lewis E","Heerspink HJL","Casartelli D","Inker LA","Passerini P","Fervenza F","Raz I","Rauen T","Moroni G","Tang C","Maes BD","Locatelli F","Torres V","de Jong PE","Perna A","Becker GJ","Appel GB","Estacio RO","Jafar TH","Eknoyan G","Hou FF","Caravaca-Fontan F","Montagnino G","Saddelli M","Gaspari F","Perrone RD","Carlo M","Chan JC","Ponticelli C","Kusek J","Wied S","Schena FP","Chapman A","Gamba S","Brenner BM","Seikrit C","Del Vecchio L","Luo J","Yu A","Hanratty R","Schrier RW"],"additional_accession":[]},"is_claimable":false,"name":"Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD.","description":"<h4>Significance statement</h4>Changes in albuminuria and GFR slope are individually used as surrogate end points in clinical trials of CKD progression, and studies have demonstrated that each is associated with treatment effects on clinical end points. In this study, the authors sought to develop a conceptual framework that combines both surrogate end points to better predict treatment effects on clinical end points in Phase 2 trials. The results demonstrate that information from the combined treatment effects on albuminuria and GFR slope improves the prediction of treatment effects on the clinical end point for Phase 2 trials with sample sizes between 100 and 200 patients and duration of follow-up ranging from 1 to 2 years. These findings may help inform design of clinical trials for int","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jun","modification":"2026-06-02T08:22:19.573Z","creation":"2026-05-26T03:07:11.539Z"},"accession":"S-EPMC10278784","cross_references":{"pubmed":["36918388"],"doi":["10.1681/ASN.0000000000000117","10.1681/asn.0000000000000117"]}}