EUCTR2013-001193-14-PL进行中（未招募）不适用
randomized, placebo-controlled, double-blind, parallel group, multicenter study to investigate the efficacy and safety of 5 fixed doses of BAY 85- 934 administered orally in the correction of anemia in pre-dialysis subjects with chronic kidney disease not currently treated with erythropoiesis-stimulating agent in Europe and Asia Pacific
试验速览
- 阶段
- 不适用
- 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
- •Women without childbearing potential
- •Male or female subjects = 18 years of age with anemia of CKD at screening
- •Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] 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)
- •Not treated with any ESA within 8 weeks before randomization
- •Mean screening Hb concentration = 10.5 g/dL (mean of all local laboratory Hb measurements [at least 2 measurements must be taken = 2 days apart] during the 4 week screening period with the last screening Hb measurement within 10 days prior to randomization, AND all measurements come from the same local laboratory for any given subject, AND the difference between the lowest value and the highest value is = 1.2 g/dL). Re screening of subjects who fail the Hb inclusion
- •criterion is allowed only once 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. At least 1 measurement should be within 10 days prior to randomization.
- •Serum ferritin levels = 100 µg/L and < 1000 µg/L OR transferrin saturation = 20% at screening. Re-screening of subjects is allowed only once. Iron supplementation is allowed. (See Section 6.9 for details about iron treatment during the study.)
- •Folate and Vitamin B12 values above the lower limit of normal. Supplementation is allowed; re-screening of subjects who fail the folate and vitamin B12 inclusion criterion is allowed only once after the initial screen
- •Body weight of 45 kg to 125 kg, inclusive, at screening
- •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 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 agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
- •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)
- •Subjects treated with any ESA within the 8 weeks before randomization
- •- Subjects known to be hyporesponsive (e.g., Hb levels < 10.0 g/dL and weekly epoetin beta doses = 9,000 IU) to ESA therapy should not be included in the study. Prior dose of ESA, if used in the past, should be recorded in concomitant medication eCRF
- •BAY 85 3934 is eliminated via uridinediphosphoglucuronosyltransferase 1 family, polypeptide A1 (UGT1A1),
- •therefore the following UGT1A1 inhibitors have to be excluded within 7 days prior to randomization:
- •- Anti-retroviral drugs, e.g., ritonavir, saquinavir, atazanavir, indinavir, lopinavir, nefinavir
- •- Tyrosine kinase inhibitors, e.g., erlotinib, pazopanib, nilotinib, sorafenib, regorafenib
- •- Other drugs, e.g., tranilast, paracetamol / acetaminophen (single oral doses allowed; prescribed continuous dosing is not allowed), probenecid, phenobarbital
- •Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
- •History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from initial screening visit
- •New York Heart Association Class III or IV congestive heart failure
- •Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as BP = 180/110 mmHg or systolic blood pressure < 95 mmHg, respectively
- •Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter , prolonged QT > 500 msec, third degree atrioventricular [AV] block if not treated with a pacemaker
- •Women of childbearing potential or pregnant or breast feeding women
研究者
相似试验
进行中（未招募）
不适用
Randomized, placebo controlled, double-blind, parallel group, multicentric Phase IV study on the clinical efficacy of lactic acid bacteria in form of hard capsules (capsule contains not less than 2 x 109 CFU of liophilisated lactic acid bacteria Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12) in ration 1:1) as prevention of antibiotic associated acute diarrhea in adults.Antibiotic associated diarrheaEUCTR2009-010713-69-SIek Pharmaceuticals d.d.200
已完成
3 期
Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injuryAcute spinal cord injuryJPRN-UMIN000018752Chiba University Hospital88
已完成
3 期
Phase 3 study of GGS in patients with microscopic polyangiitis (MPA)Microscopic polyangiitis (MPA)JPRN-jRCT2080222344TEIJIN PHARMA LIMITED36
已完成
3 期
Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor for patients with acute spinal cord injuryAcute spinal cord injuryJPRN-jRCT2091220217Coordinating Committee88
进行中（未招募）
不适用
Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.EUCTR2006-002204-33-NLCB Pharma S.A.317