CTRI/2013/09/004005进行中（未招募）3 期
Prospective, multi-centre, randomized, open-label, twoarm,parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-026/ Aranesp® when given subcutaneously in patients for correction of anemia due to Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 21
- 主要终点
- The primary efficacy will be assessed by Hemoglobin responder rate i.e., proportion of patients achieving 1 g/dL rise in Hb from baseline at Week 8
研究概览
简要总结
This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The present study will evaluate the efficacyxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
safety to evaluate efficacy and safety of R-TPR-026 and Aranesp® when given subcutaneously in patients for correction of anemia due to Chronic Kidney Disease.
The primary outcome measures will be assessed by Hemoglobin responder rate i.e., proportion of patients achieving >1 g/dL rise in Hb from baseline at Week 8. 105 subject will be recruited from 08 sites in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Diagnosed with anemia due to Chronic Kidney Disease (CKD) 2 On hemodialysis or peritoneal dialysis prior to enrollment in the study 3 ESA therapy naive or ESA therapy-free for at least 3 months 4 Hb < 9 g/dL based on two screening visits at least 7 days apart 5 TSAT ≥ 20% 6 Females of childbearing potential should be willing to use an approved method of double-barrier contraception and should have a negative pregnancy test.
- •7 Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
排除标准
- •Current severe, uncontrolled systemic disease (e.g., clinically significant hematological disease such as sickle cell anemia, myelodysplasia, hematological malignancy, hemolytic anemia, inflammatory, infectious, psychiatric or other conditions interfering with erythropoietic response)
- •RBC transfusion to treat anemia within 8 weeks before enrollment or scheduled to receive RBC transfusion
- •New York Heart Association class III or IV Congestive Heart Failure
- •Uncontrolled hypertension (Diastolic BP 110 mmHg or systolic BP 180 mmHg) during screening
- •Major surgical procedure in last 12 weeks before enrollment or anticipation of the need for major surgery during the course of study treatment
- •Androgen therapy within 12 weeks prior to start of study
- •Scheduled to receive a renal transplant
- •Cardiovascular disease (Acute myocardial infarction or hospitalization for CHF within 12 weeks before enrollment)
- •Evidence of conditions like deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment
- •Uncontrolled hyper parathyroidism 1500 pg/ml during last 12 months
- •Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
- •History of intolerance or hypersensitivity to darbepoetin alfa
- •Pregnant or breast-feeding women
- •Women of child bearing potential who are not using effective contraception during participation in the study and do not agree to do so for at least 28 days after final dose of investigational product.
- •Participation in any study within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study
- •Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
结局指标
主要结局
The primary efficacy will be assessed by Hemoglobin responder rate i.e., proportion of patients achieving 1 g/dL rise in Hb from baseline at Week 8
时间窗: week 8
次要结局
- Proportion of patients achieving rise in hemoglobin i.e., 1 g/dL rise from baseline, at Week 24(week 24)
- Average dose of R-TPR-026/Aranesp® administered for achievement of rise of hemoglobin in the target range (9-12 g/dL) at Week 24(week 24)
- Proportion of patients maintaining mean Hb within target range (9-12 g/dL) at Week 24(week 24)
- Mean change in Hb level between the screening/baseline period and end of the study(week 24)
- Pharmacokinetic parameters (Cmax and AUC0-168) will be calculated for single dose of R-TPR-026 and Aranesp®(week 24)
- Pharmacodynamic parameter(o Reticulocyte count assessed at Day 2 and Day 4 of Week 0, every week from Week 1 to Week 8, every alternate week from Week 10 to Week 20 and every week from Week 21 to Week 24)
- Evaluation of safety(week 24)
研究者
研究点 (21)
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