JPRN-jRCT2080223471已完成3 期
Phase 3 study of subcutaneously-administered SK-1401 in patients with non-dialysis chronic kidney disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
研究概览
简要总结
In subjects with renal anemia associated with conservative chronic kidney disease treated with ESA, safety and efficacy were confirmed after the switched treatment from ESA to SK-1401 administered subcutaneously for 1 year.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Patients with non-dialysis chronic kidney disease
- •- Patients treated with each of the following medicine: darbepoetin alfa, epoetin alfa, epoetin beta or epoetin beta pegol
- •- Patients with hemoglobin concentration between 10g/dL - 12.0g/dL (both inclusive)
排除标准
- •- Patients with history of massive bleeding or erythrocyte transfusion
- •- Patients with apparent hemorrhagic lesion
- •- Patients with malignant tumor
研究者
相似试验
已完成
3 期
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in JapanHemodialysis Dependent Chronic Kidney Disease AnemiaNCT03439137Tanabe Pharma Corporation323
已完成
2 期
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary HyperparathyroidismSecondary HyperparathyroidismNCT03226171Sanwa Kagaku Kenkyusho Co., Ltd.58
已完成
3 期
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in JapanHemodialysis Dependent Chronic Kidney Disease AnemiaNCT03461146Tanabe Pharma Corporation24
已完成
不适用
Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO InjectionsRenal Insufficiency, ChronicOrgan GraftNCT03481686Rennes University Hospital9
已完成
3 期
Phase 3 Study of SK-1403Secondary HyperparathyroidismNCT03801980Sanwa Kagaku Kenkyusho Co., Ltd.153