CTRI/2019/06/019635已完成3 期
A Phase 3, Multicenter,Multicountry, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients with Chronic Kidney Disease (CKD) who are not on Dialysis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 531
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin
- •concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
- •2. Ability to understand and give informed consent for participation.
- •3. Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis)
- •defined by estimated glomerular filtration rate (eGFR) using the CKD
- •Epidemiology Collaboration (CKD-EPI) formula.
- •4. Male or female, 18 to 80 years of age.
- •5. Body weight > 40 kg.
- •6. Subjects not on dialysis and not expected to start dialysis during the study period.
- •7. Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy
- •within 6 weeks prior to enrollment.
- •8. Estimated GFR >=10 mL/min/1.73 m2.
- •9. Serum ferritin >=100 ng/mL and/or TSAT >20%.
- •10. No iron, folate or Vitamin B12 deficiency.
- •11. Females of childbearing potential, must agree to use one of the approved
- •contraception methods, from screening until completion of the follow-up visit.
排除标准
- •1. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- •2. Intravenous iron within 14 days prior to enrollment.
- •3. Prior exposure of rhEPO analogues less than 04 weeks.
- •4. Red blood cell transfusion within 8 weeks prior to enrollment.
- •5. History of previous or concurrent cancer.
- •6. Serologic status reflecting active hepatitis B or C infection or
- •Human immunodeficiency virus (HIV) infection.
- •7. Active infection prior to enrollment.
- •8. History of renal transplant.
- •9. Major surgery within 90 days of the first day of study drug dosing, and minor
- •surgery within 30 days of the first day of study drug dosing.
- •10. Unable to swallow tablets or disease significantly affecting gastrointestinal function
- •and/or inhibiting small intestine absorption such as; mal-absorption syndrome,
- •resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
- •11. History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
研究者
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