KCT0006024已完成未知
A multi-center, multi-national, double-blind, randomized, active-controlled, parallel-group clinical study to assess safety and efficacy of PDA10 (epoetin-alfa) compared to Eprex® in patients with anemia of chronic renal failure
PanGen Biotech0 个研究点目标入组 316 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 316
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •To be eligible to participate in the study, patients must meet the following criteria:
- •1.Anemic patients with end stage renal failure (ESRD) on chronic hemodialysis
- •2.Patients must be at least 18 years old but less than 75 years old at Screening Visit
- •3.Patients on hemodialysis through a functioning native arterio-venous fistula
- •4.Patients must be at their dry body weight or within 5% of it during the baseline period (observation period)
- •5.Patients must be able to understand the information provided to them and to give written Informed Consent
- •6.Female patients of childbearing potential must have a negative serum pregnancy test at the Screening Visit and Baseline Visit. Females must be surgically sterile, postmenopausal for at least 1 year prior to Screening Visit or must be using an acceptable method of birth control ([oral, non-oral or implantable] hormone contraceptives, intrauterine contraceptive device or blockers and spermicides) effectively. Abstinence is not an acceptable method of contraception for the study.
- •7.Patients must have the following at Screening Visit or prior to randomization as well as at the baseline period (or observation period)
- •?Patients on erythropoietin treatment prior to Screening
- •Note: If patients who have been on Eprex® treatment before this study
- •have hemoglobin level less than 10 g/dl during the baseline period (observation period), they must participate in the titration phase.
- •?Hemoglobin level with 10 - 12 g/dl and a stable IV dose of Eprex® without transfusion prior to randomization (A stable IV dose is defined as not more than 25% change up or down in weekly dose and no clinically relevant change of regimen in frequency of haemodialysis for the baseline period [observation period])
- •?Patients on Eprex® treatment for at least 12 weeks; patients on stable and adequate hemodialysis at least 3 times a week and with a documented URR > 65% or delivered KT/V = 1.2 in the past 6 months prior to randomization (If patients meet this criteria, they will be randomized without participating in the titration phase)
- •?Serum ferritin level at least 100 ng/ml and/or transferrin saturation (TSAT) at least 20% prior to randomization
排除标准
- •Patients who meet any of the following criteria will not be eligible to participate in the study:
- •1.Patients with a temporary or permanent catheters or synthetic grafts
- •2.Patients with uncontrolled hypertension, defined as a pre-dialysis diastolic BP of greater than 110 within 12 weeks prior to randomization
- •3.Patients with severe diseases within the last 6 months prior to randomization (e.g. stroke, transient ischemic attack, myocardial infarction, cerebrovascular accident, coronary artery bypass graft, deep venous thrombosis, unstable angina, decompensate congestive heart failure (New York Heart Association [NYHA] class III~IV), or other thromboembolic events)
- •4.Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis or treatment
- •5.Patients with a current or recent known history of a severe hyperparathyroidism or (PTH > 1500 pg/ml within 12 weeks prior to randomization.)
- •6.Patients with hyperkalemia
- •7.Patients with epilepsy
- •8.Patients with malnutrition (serum albumin < 3.5g/dl prior to randomization)
- •9.Patients with an acute infection, acute hepatitis (including A, B, C type) or chronic hepatitis B or C requiring treatment , or HIV infection
- •10.Patients with significant inflammation (CRP >30 mg/L within 12 weeks prior to randomization)
- •11.Patients with a history of gastrointestinal bleeding within the last 6 months before Screening
- •12.Patients with any active, uncontrolled systemic or inflammatory disease that in the Investigator's opinion may be significant to exclude participation in the study
- •13.Patients of need for blood transfusions within 12 weeks prior to randomization
- •14.Patients with history of pure red cell aplasia (PRCA) or anti-erythropoietin antibodies
- •15.Patients with a history of malignancy of any organ system within the last 5 years prior to Screening
- •16.Patients with a current diagnosis of anemia due to folic acid and/or Vitamin B12 deficiencies, hemolysis, or gastrointestinal bleeding or a history of active blood or bleeding disorders within the last 6 months before Screening
- •17.Patients who have received immunosuppressive treatment or use of other medication known to influence erythropoiesis 12 weeks prior to randomization
- •18.Patients with hypersensitivity to the active substance or to any of the excipients
- •19.Patients who have been treated with any other investigational drug within 4 weeks prior to Screening
- •20.Patients who currently are pregnant or lactating
- •21.Patients who are not cooperative or not able to follow the clinical study procedures
- •22.Patients who are judged to be ineligible to the clinical study at the Investigator’s discretion for other reasons such as alcohol and drug abuse
研究者
相似试验
进行中（未招募）
1 期
A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated diarrhea - A double-blind, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1 Level: LLT Classification code 10012748 Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-BEOptimer Pharmaceuticals Inc.664
进行中（未招募）
不适用
A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated diarrhea - A double-blind, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-SEOptimer Pharmaceuticals, Inc.664
进行中（未招募）
不适用
A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated diarrhea - A double-blind, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-DEOptimer Pharmaceuticals, Inc.664
进行中（未招募）
1 期
A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated diarrhea - A double-blind, randomised study of PAR-101 vs vancomycin in CDADClostridium difficile associated diarrhoea (CDAD)MedDRA version: 8.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileEUCTR2006-004291-12-GBOptimer Pharmaceuticals, Inc.664
进行中（未招募）
不适用
A double-blind, multi-center, multinational, randomized withdrawal study evaluating the efficacy and safety of SR58611A (350 mg q12) versus placebo in the prevention of depression relapse up to 1 year in patients with Major Depressive Disorder improved after 12 weeks of open treatment with SR58611A (350 mg q12) - CALYPSOpatients with major depressive disorderMedDRA version: 8.0Level: LLTClassification code 10018105EUCTR2005-004006-81-FIsanofi-aventis recherche & développement800