NCT04012957已完成3 期
A Phase 3, Multicenter, Multi-country, 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 30
- 主要终点
- Hemoglobin level
研究概览
简要总结
This is a phase III, multicenter, multi-country, 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 CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
- •Ability to understand and give informed consent for participation.
- •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.
- •Male or female, 18 to 80 years of age.
- •Body weight > 40 kg.
- •Subjects not on dialysis and not expected to start dialysis during the study period.
- •Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
- •Estimated GFR ≥10 mL/min/1.73 m
- •Serum ferritin ≥100 ng/mL and/or Transferrin Saturation >20%.
- •No iron, folate or Vitamin B12 deficiency.
- •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
- •Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- •Intravenous iron within 14 days prior to enrollment.
- •Prior exposure of rhEPO analogues less than 04 weeks.
- •Red blood cell transfusion within 8 weeks prior to enrollment.
- •History of previous or concurrent cancer.
- •Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
- •Active infection prior to enrollment.
- •History of renal transplant.
- •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.
- •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.
- •History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
- •Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.
- •History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- •History of severe allergic or hypersensitivity to investigational products and its excipients.
- •Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists or other medications within 28 days of the first dose of study drug that in the investigator's opinion, could compromise patient safety.
- •Pregnant and breastfeeding women.
- •Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
- •Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
- •Presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the Investigator's opinion, could compromise the patient's safety.
- •History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day).
- •History of difficulty with donating blood.
- •History or presence of any clinically significant ECG abnormalities during screening.
- •Participants who have participated in any drug research study other than the present trial within past 3 months.
- •Participants who have donated one unit (350 ml) of blood in the past 3 months or history of whole blood transfusion in last 120 days prior to enrollment.
- •History of chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease, Systemic Lupus Erythematosus [SLE]).
- •In case of Diabetes mellitus patients, glycosylated haemoglobin (HbA1c) >9 %.
研究组 & 干预措施
Darbepoetin Alfa Injection
Experimental
Randomly assigned to receive Darbepoetin in a 1:1 ratio for 24 weeks.
干预措施: Darbepoetin Alfa (Drug)
Desidustat oral tablet
Active Comparator
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
干预措施: Desidustat Oral Tablet (Drug)
结局指标
主要结局
Hemoglobin level
时间窗: 24 weeks
Change in Hb levels from baseline
次要结局
- Hemoglobin Response(24 weeks)
- Hemoglobin target range(24 weeks)
研究者
研究点 (30)
Loading locations...
相似试验
已完成
3 期
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)Carcinoma, Renal CellNCT02627963AVEO Pharmaceuticals, Inc.350
已完成
3 期
Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based ChemotherapyNon-squamous NSCLCHER2 Exon 20 MutationNCT04447118Jiangsu HengRui Medicine Co., Ltd.151
已完成
3 期
A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell CarcinomaAdvanced Renal Cell CarcinomaNCT01030783AVEO Pharmaceuticals, Inc.517
终止
3 期
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast CancerMetastatic Breast CancerNCT02144012Hoffmann-La Roche49
已完成
3 期
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma PatientsOral Mucositis (Ulcerative) Due to RadiationNCT03387774Sun Yat-sen University179