IRCT201601156135N6已完成3 期
A Phase III, randomized, two armed, multicenter, parallel, double blind (patient and assessor blinded), active controlled non inferiority clinical trial to determine the non inferior therapeutic efficacy and safety between Beta erythropoietin ®(CinnaPoietin) and Eprex® (epoetin alpha) on treatment of anemia in End stage renal disease (ESRD) hemodialysis patients
CinnaGen Pharmaceutical Company0 个研究点目标入组 156 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
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
- 年龄范围
- 18 years 至 70 years（—）
- 性别
- All
入选标准
- •Aged between 18 and 70
- •ESRD patients who are on hemodialysis for =3 months.
- •Hb level 8- 11.5 g/dl
- •Patients are on adequate hemodialysis: the minimally adequate dose of hemodialysis given 3 times per week should be a spKt/V (single-pool delivered Kt/V; clearance of urea x dialysis time/volume of distribution) of 1.2 per dialysis. For treatment periods of less than 5 hours, an alternative minimum dose is a urea reduction rate (URR) of 65%. All types of hemodialysis systems and hemodiafiltration, including high-flux membranes are allowed as long as there is no plan to change the patient’s regimen during the study.
- •Sufficient iron stores, defined as serum ferritin = 200 ng/ml and transferrin saturation =20%. (Patients not meeting these criteria may receive iron supplementation therapy during the Screening and stabilization period to appropriately correct their iron store deficiency to meet the criterion required for randomization);
- •who present iron stores according to the KDIGO guidelines;
- •Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
- •Females of childbearing potential agree to use an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
- •Qualified and willing to sign the informed consent form with the commitment of complying with all the scheduled visits, and study procedures as judged by the investigator;
- •In any circumstances that potential participants are not able to give consent, it may be given by responsible parents or guardian.
排除标准
- •Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure = 100 mmHg or systolic blood pressure =180 mmHg);
- •Anemia secondary to other causes different to the CKD (e.g. multiple myoloma, aplastic anemia, leukemia;….)
- •Decompensated liver failure;
- •Clinical evidence of concurrent uncontrolled hyperparathyroidism (defined as serum parathyroid hormone (iPTH) > 800 pg/ml);
- •Heart failure [New York Heart Association (NYHA) class III and IV];
- •Unstable angina pectoris, active cardiac disease, stroke and/or cardiac infarction within the last six months;
- •History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last six months.
- •Thrombocytosis (platelet count > 500,000/µl);
- •Thrombocytopenia (platelet count < 100,000/µl);
- •White blood cell count < 3,000/µl);
- •White blood cell count >15,000)
- •Recent Bleeding (acute or chronic bleeding within three months prior to screening);
- •Suspicion of or confirmed occult bleeding (increased reticulocyte count);
- •Clinical evidence of concurrent systemic infection, or inflammatory disease (e.g; diabetic foot, bed sore, access infection, CRP> 30,…)
- •Currently receiving treatment for epilepsy;
- •Major surgery within 3 months prior to randomization and during the conduct of the trial (except vascular access surgery);
- •Concomitant immunosuppressive therapy; patients on a short course of steroids (up to 7 days), topical or intranasal steroids are allowed in the study;
- •History of any malignant disease within the last 5 years (except excised non-melanoma skin cancer);
- •Women who are pregnant or breastfeeding;
- •Known history of severe drug-related allergies;
- •Known history of drug related allergy to Erythropoietin or one of the ingredients of the test or the reference produc
研究者
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