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
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 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
- •1. 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)
- •2. RBC transfusion to treat anemia within 8 weeks before enrollment or scheduled to receive RBC transfusion
- •3. New York Heart Association class III or IV Congestive Heart Failure
- •4. Uncontrolled hypertension (Diastolic BP 110 mmHg or systolic BP 180 mmHg) during screening
- •5. Major surgical procedure in last 12 weeks before enrollment or anticipation of the need for major surgery during the course of study treatment
- •6. Androgen therapy within 12 weeks prior to start of study
- •7. Scheduled to receive a renal transplant
- •8. Cardiovascular disease (Acute myocardial infarction or hospitalization for CHF within 12 weeks before enrollment)
- •9. Evidence of conditions like deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment
- •10. Uncontrolled hyper parathyroidism 1500 pg/ml during last 12 months
- •11. 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
- •12. History of intolerance or hypersensitivity to darbepoetin alfa
- •13. Pregnant or breast-feeding women
- •14. 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.
- •15. Subjects with HIV, HBsAg, HCV test positive.
- •16. 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
- •17. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
研究者
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