Composite end point can be useful in future CKD progression studies
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A composite end point that includes low eGFR, declining eGFR and kidney replacement therapy proved to be useful when studying chronic kidney disease progression, according to data published in Kidney Medicine.
“Kidney failure is an important outcome for monitoring and investigating the progression of chronic kidney disease, but this outcome is not always available in many chronic kidney disease research studies,” Jarcy Zee, PhD, assistant professor of biostatistics at the University of Pennsylvania, and colleagues wrote. They added, “The aim of the current study was to investigate the power and predictive ability of surrogate kidney failure end points in a population with moderate-to-advanced CKD.”
In an analysis of longitudinal data of the Chronic Kidney Disease Outcomes and Practice Patterns Study, researchers measured eGFR in patients from Brazil, France, Germany and the United States (median age was 71 years; 59% were men) with stages 3 to 5 CKD.
Researchers considered reaching an eGFR of less than 15 mL/min/1.73 m² or eGFR decline of at least 40% the primary outcome, in addition to the composite end points of these separate end points. Using the Cox model, researchers used each end point as a time-varying indicator to estimate the time to kidney replacement therapy and was measured by the number of events and prediction accuracy.
During a median follow-up of 2.7 years, 8,211 patients showed a median baseline eGFR of 27 mL/min/1.73 m² and 1,448 kidney replacement therapy events. The eGFR end point showed a better prognostic ability than the 40% eGFR decline among patients with stage 4 CKD, but the end points were similar to patients with stage 3 CKD. Researchers determined the combination of eGFR of less than 15 mL/min/1.73 m² and 40% eGFR decline showed the highest prognostic ability for estimating kidney replacement therapy.
“This study provides empirical evidence that a potential surrogate end point that combines kidney replacement therapy, a low eGFR and a percentage eGFR decline can accurately represent kidney replacement therapy while increasing the number of outcome events among patients with advanced CKD and in a multinational, real-world setting,” Zee and colleagues wrote. They added, “The harmonized use of this approach for patient-centered kidney failure outcomes in clinical research will accelerate the translation of new discoveries to clinical practice, such as the identification of modifiable risk factors of kidney failure and effective treatments to prevent kidney failure.”
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