NCT02586402Unknown2 期
A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Pegolsihematide for the Correction of Anemia in Patients With CRF Undergoing Dialysis and Previously Treated With ESAs
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Average reticulocytes and hemoglobin change from baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg)
- •Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization.
- •On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week
- •Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening
- •Patients with a transferrin saturation≥ 20% and a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
- •Signed informed consent
排除标准
- •Pregnant or lactating females
- •Red blood cell transfusion within 3 months prior to randomization
- •Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products
- •hemolytic syndromes or coagulation disorder
- •hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia),
- •Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
- •C Reactive Protein (CRP) greater than 30 mg/L within the 4 weeks prior to randomization
- •Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH>800pg/ml)
- •Poorly controlled hypertension within 4 weeks prior to randomization
- •Chronic congestive heart failure (New York Heart Association Class Ⅲ or IV)
- •significant symptom within 6 months prior to randomization (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, A positive test for HIV antibody or ALT> 2 x upper limit of normal (ULN), AST> 2 x upper limit of normal (ULN))
- •tumor malignancy
- •Expected survival less than 12 months
- •A scheduled kidney transplant
- •Major surgery (may Massive bleeding) during the study
- •expected conception within 4 Weeks after the end of the Study Treatment
- •The subject has participated in other clinical trial within the 12 weeks prior to randomization
- •Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
研究组 & 干预措施
Pegolsihematide
Experimental
Participants received Pegolsihematide by intravenous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
干预措施: pegol-Sihematide (Drug)
Epoetin Alfa
Active Comparator
Epoetin Alfa administration 1 to 3 times per week. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
干预措施: Epoetin Alfa (Drug)
结局指标
主要结局
Average reticulocytes and hemoglobin change from baseline
时间窗: Baseline to Week 16
次要结局
- Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16(week 12 to 16)
- Average RBC, hematokrit and reticulocytes change from baseline(Baseline to Week 16)
- Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16(week 12 to 16)
- Incidence of adverse events and serious adverse events(Baseline to Week 16)
研究者
研究点 (1)
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