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MechanismEPO receptor agonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date01 Jun 1989 |
A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.
达依泊汀α注射液替换重组人促红素注射液治疗慢性肾功能衰竭血液透析患者贫血的非劣效性试验(III期)
[Translation] Non-inferiority trial of darbepoietin α injection replacing recombinant human erythropoietin injection in the treatment of anemia in hemodialysis patients with chronic renal failure (Phase III)
以接受HD治疗的稳定期慢性肾功能衰竭患者为对象,通过对照比较,验证达到目标Hb浓度(10.0 g/dL≦Hb浓度≦12.0 g/dL)时达依泊汀α注射液的安全性及贫血改善效果不劣于重组人促红素。
[Translation] In patients with stable chronic renal failure receiving HD treatment, a control comparison was performed to verify that the safety and anemia-improving effect of darbepoietin α injection were not inferior to recombinant human erythropoietin when the target Hb concentration (10.0 g/dL ≦ Hb concentration ≦ 12.0 g/dL) was reached.
以重组人促红素注射液为对照的达依泊汀α注射液治疗慢性肾功能衰竭血液透析患者贫血的非劣效性试验
[Translation] A non-inferiority trial of darbepoietin α injection compared with recombinant human erythropoietin injection in the treatment of anemia in hemodialysis patients with chronic renal failure
以HD患者中未接受过ESA给药的患者为对象,通过对照比较,验证达到目标Hb浓度(10.0 g/dL≦Hb浓度≦12.0 g/dL)时达依泊汀α注射液的安全性及贫血改善效果不劣于重组人促红素。
[Translation] Through control comparison, we used HD patients who had not received ESA administration as the subjects to verify that the safety and anemia improvement effect of darbepoietin α injection were not inferior to recombinant human erythropoietin when the target Hb concentration (10.0 g/dL ≦ Hb concentration ≦ 12.0 g/dL) was reached.
100 Clinical Results associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.
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100 Deals associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Kyowa Hakko Kirin China Pharmaceutical Co., Ltd.