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 (eGFRcr) equation is being adopted in the US. 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. Whilst acknowledging these challenges, GSK decided to adopt the CKD-EPI 2021 eGFRcr equation for new adult trials to support health equity and delivery benefits from standardized data management. The eGFRcr 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/1.73m2 inclusion criterion, since 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 endpoints or relevant safety concerns. GSK plans to monitor the impact of adopting the CKD-EPI 2021 eGFRcr equation on adverse event reporting across studies and pharmacovigilance outcomes, and to monitor the evolution of regulatory guidance for eGFR equation implementation.