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Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of CKD: A Scientific Workshop Sponsored by the National Kidney Foundation in Collaboration With the US Food and Drug Administration and European Medicines Agency

American Journal of Kidney Diseases · 2019 · Vol. 75(1) · pp. 84–104
Andrew S. LeveyRon T. GansevoortJosef CoreshLesley A. InkerHiddo J.L. HeerspinkMorgan E. GramsTom GreeneHocine TighiouartKunihiro MatsushitaShoshana H. BallewYingying SangEdward F. VoneshJian YingTom ManleyDick de ZeeuwKai‐Uwe EckardtAdeera LevinVlado PerkovicLuxia ZhangKerry Willis
Chronic Kidney Disease and DiabetesRenal Diseases and GlomerulopathiesDialysis and Renal Disease ManagementMedicineRenal functionKidney diseaseAlbuminuriaClinical trialObservational studyHazard ratioCreatinineInternal medicineIntensive care medicine

MeSH terms

AlbuminuriaBayes TheoremCreatinineEuropeGlomerular Filtration RateHumansKidney Failure, ChronicUnited StatesUnited States Food and Drug AdministrationBiomarkersDrug ApprovalDisease ProgressionRenal Insufficiency, Chronic

Funding

  • AstraZeneca
  • Bayer
  • Merck
  • Novartis
  • Gilead Sciences
  • Alexion Pharmaceuticals
  • AbbVie
  • Tufts Medical Center
  • Boehringer Ingelheim
  • Ironwood Pharmaceuticals, Incorporated
  • Astellas Pharma Canada
  • Kyowa Hakko Kirin
  • Novo Nordisk
  • Siemens
  • Servier
  • Ipsen
  • National Institutes of Health
  • Sanofi Genzyme
  • Relypsa
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Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of CKD: A Scientific Workshop Sponsored by the National Kidney Foundation in Collaboration With the US Food and Drug Administration and European Medicines Agency · Scinovex