Reflection on the Evaluation Indicators for Drug Efficacy in Treatment of Kidney Disease
OBJECTIVE To discuss technical considerations for the design of efficacy evaluation indicators for drugs used in the treatment of kidney disease.METHODS Based on practical experience in disease characteristics,drug development,and evalua-tion,technical recommendations were proposed for designing efficacy evaluation indicators for kidney disease treatment drugs.RESULTS and CONCLUSION Renal failure and cardiovascular death are considered as the primary clinical outcomes for evalua-ting the efficacy of drugs used in kidney disease treatment.Based of the urgent clinical need and slow progression of kidney disease,exploring the selection and application of intermediate/surrogate indicators holds significant clinical value.Some evidence suggests that improvement in estimated glomerular filtration rate(eGFR)slope can partially predict the clinical benefits of treatment on chronic kid-ney disease(CKD)progression,making it a potential alternative indicator for early or slowly progressing CKD patients in drug trials.The correlation between elevated urinary protein levels and duration with renal function loss in lupus nephritis,membranous nephropa-thy,and IgA nephropathy indicates their potential for predicting renal outcomes;however,further research evidence is still required.In conclusion,when selecting indicators to evaluate efficacy,scientific design should be based on trial objectives,target population characteristics,drug mechanisms of action,and effect intensity while carefully considering surrogate indicators.
万方数据
维普
