PDF
Full
Outline
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 overall 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 suggest 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.
PDF
197
93
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
