Pharmaceutical Practice Considerations Regarding Adoption of the Race-Free Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 Equations

Abstract

The race-free Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 estimated glomerular filtration rate-creatinine (eGFR_cr) equation is being adopted in the United States. Elsewhere there is debate regarding its validation and adoption. Absence of a perfect solution and a lack of alignment present challenges when considering global clinical trials. While acknowledging these challenges, GSK decided to adopt the CKD-EPI 2021 eGFR_cr equation for new adult trials to support health equity and delivery benefits from standardized data management. The eGFR_cr obtained using the CKD-EPI 2021 equation versus CKD-EPI 2009 equation is moderately lower in US Black individuals and moderately higher in non-Black individuals. Analyses before adoption suggested no major impact for study safety or efficacy evaluations although racial/ethnic representation may need to be examined in trials with an eGFR ≥ 60 mL/min/1.73 m² inclusion criterion because enrollment of eligible Black participants could be reduced. Sensitivity analyses using 2009 and 2021 equations may be necessary to understand any effect size with population change, especially where there are kidney end points or relevant safety concerns. GSK plans to monitor the impact of adopting the CKD-EPI 2021 eGFR_cr equation on adverse event reporting across studies and pharmacovigilance outcomes and to monitor the evolution of regulatory guidance for eGFR equation implementation.

Keywords: CKD-EPI 2009; CKD-EPI 2021; Chronic kidney disease; clinical trial; eGFR; equation; ethnicity; health equity; kidney function; pharmaceutical; race; representation.