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

Bayer HealthCare AG0 个研究点目标入组 120 人开始时间: 2013年10月1日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•- 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 10.0 to 12.0 g/dL
•- 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

•- 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 (such as sickle cell disease and thalassemia major)
•- 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) even if it is currently in remission
•- 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)

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