Key Technical Considerations in the Drugs Design of Clinical Trials for Delaying the Progression of Chronic Kidney Disease
OBJECTIVE To explore the key technical considerations in the drugs design of clinical trials for delaying the progression of chronic kidney disease.METHODS By reviewing domestic and foreign literature,and considering the characteristics of the disease,drug development and review experience,the important design considerations for clinical trials evaluating drugs that delay the progression of chronic kidney disease were suggested in this article.RESULTS and CONCLUSION We recommend an o-verall trial design that incorporates randomization,double-blinding,and placebo/standard treatment as control measures.The study population should be representative of a wide range of individuals who reflect the intended objectives of the trial.Inclusion criteria and efficacy evaluation should take into account etiology,staging,risk factors for disease progression,and combined treatments.We sug-gest the composite endpoints based on clinical events as primary efficacy endpoints,while the average change rate in glomerular filtration rate is recommended for early or slowly progressing chronic kidney disease cases.Safety evaluation indicators should not only adhere to general standards but also consider potential safety issues related to investigational drugs as well as safety signals associated with natural disease progression by setting corresponding safety assessment parameters for underlying diseases.
chronic kidney diseaseclinical trialsslow progressiondrug development
万方数据
维普
