EUCTR2013-001192-21-BG进行中（未招募）1 期
A randomized, parallel group, open-label, multicenter study to investigate the efficacy and safety of oral BAY 85-3934 and active comparator (darbepoetin alfa) in the maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment in Europe and Asia Pacific
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female subjects = 18 years of age with anemia of chronic kidney disease (CKD) at screening
- •- Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease or the formula according to Matsuo, et al.)
- •- Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
- •- Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization
- •- At least one kidney
- •- Mean screening Hb concentration of 9.0 to 12.0 g/dL, inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken = 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL, AND all measurements must come from the same local laboratory for any given subject, AND the difference between the lowest level and the highest level is = 1.2 g/dL).
- •Re-screening of subjects who fail the Hb inclusion criterion is allowed only once with a minimum of 4 weeks after the initial screen.
- •Note: The intention is that Hb measurements will be taken 5 to 7 days apart, but 2 days apart is the minimum.
- •- Serum ferritin levels = 100 µg/L and < 1,000 µg/L OR transferrin saturation = 20% at screening. Re-screening of subjects is allowed only once. Iron substitution is allowed.
- •- Folate and vitamin B12 values above the lower limit of normal. Rescreening of subjects who fail the folate and vitamin B12 inclusion criterion is allowed only once with a minimum of 4 weeks after the initial screen.
- •- Infertile male subjects or men who agree to use adequate contraception when sexually active or women without childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- •- Active hemolysis or diagnosis of hemolytic syndrome
- •- History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA)
- •- History of hemosiderosis or hemochromatosis
- •- Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
- •- Aplastic anemia
- •- Chronic lymphoproliferative diseases
- •- Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study
- •- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
- •- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- •- Uncontrolled and symptomatic hyperparathyroidism
- •- Uncontrolled active infection
- •- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
- •- Any allograft (including renal allograft) in place and on immunosuppressive therapy or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
- •- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonaryembolism) within the last 6 months from the initial screening visit
- •- Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as mean BP = 180/110 mmHg or systolic BP < 95 mmHg, respectively
- •- Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, third degree atrioventricular [AV] block if not treated with a pacemaker)
研究者
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