不同程度肾功能损害患者 denosumab单剂量给药研究
A single-dose study of denosumab in patients with various degrees of renal impairment?
Abstract
This 16-week study evaluated pharmacokinetics and pharmacodynamics of denosumab in 55 subjects with renal function ranging from normal to dialysis-dependent kidney failure. Participants received a single 60-mg subcutaneous dose of denosumab. Kidney function groups were based on calculations using the Cockcroft-Gault equation and U.S. Food and Drug Administration (FDA) guidance in place when the study was designed. Renal function did not have a significant effect on denosumab pharmacokinetics or pharmacodynamics. These findings suggest denosumab dose adjustment based on glomerular filtration rate is not required. Rapid decreases in serum C-telopeptide in all groups were sustained thro
学科代码:内科学 关键词:CHRONIC KIDNEY DISEASE;BONE;PH
来源: Journal of Bone and Mineral Research
来源: Journal of Bone and Mineral Research
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