A randomized, controlled, open-label, multi-center, parallel group study to demonstrate efficacy and safety of RO0503821 when administered with pre-filled syringes for the maintenance treatment of anemia in patients with chronic kidney disease who are on dialysis.

F Hoffmann-La Roche Ltd0 个研究点目标入组 264 人开始时间: 2005年2月14日最近更新: 2019年11月25日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: F Hoffmann-La Roche Ltd
入组人数: 264

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Written informed consent
•2. Adult patients (= 18 years old) with chronic renal anemia
•3. Regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 12 weeks before screening and during the screening/baseline period
•4. Kt/V =1.2 or URR =65% for patients on thrice-weekly hemodialysis or weekly Kt/V =1.8 for peritoneal dialysis patients. Hemodialysis patients with fewer or more dialysis sessions per week should have a weekly Kt/V =3.6
•5. Baseline haemoglobin concentration between 10.5 and 13 g/dL (mean of the weekly haemoglobin values determined in weekly -4 to-1)
•6. Stable baseline haemoglobin concentrations (defined as an absolute difference less than or equal to 1g/dL between the mean haemoglobin values determined in weeks -4 and -3 and the mean hemoglobin values determined in weeks -2 and -1)
•7. Continuous maintenance Epoetin therapy (Epoetin alfa formulated with human albumin or Epoetin beta) with the same dosing interval (i.e., one, two or three times weekly) and route (intravenous or subcutaneous) for at least 8 weeks before screening (a maximum of one missed does is allowed)
•8. Continuous maintenance Epoetin therapy (Epoetin alfa formulated with human albumin or Epoetin beta) with the same dosing interval (i.e., one, two or three times weekly) and route (intravenous or subcutaneous) during screening/baseline period (no missed dose is allowed)
•9. Stable maintenance Epoetin therapy (Epoetin alfa formulated with human albumin or Epoetin beta) during screening/baseline period (a maximum of one change of the weekly dose is allowed: this change should not exceed 25% compared to the weekly dose administered in the week preceding screening)
•10. Adequate iron status defined as serum ferritin = 100 ng/mL or TSAT = 20% (or percentage of hypochromic red cells < 10%);( mean of two values determined in week -4 and -3).
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 weeks before screening or during the screening/baseline period
•2. RBC transfusions within 8 weeks before screening or during the screening/baseline period
•3. Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
•4. Hemolysis
•5. Active malignant disease except non-melanoma skin cancer
•6. Chronic, uncontrolled or systematic inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus)
•7. Acute infection
•8. CRP > 30mg/L
•9. Temporary (untunneled) dialysis access catheter
•10. Vitamin B12 deficiency
•11. Folic acid deficiency
•12. Uncontrolled or symptomatic secondary hyperparathyroidism
•13. Poorly controlled hypertension necessitating interruption of Epoetin treatment in the 6 months before screening
•14. Epileptic seizure in the 6 months prior to screening
•15. Platelets > 500x109 /L
•16. Pure red cell aplasia
•17. Chronic congestive heart failure (New York Heart Association Class IV)
•18. High likelihood of early withdrawal or interruption of the study (e.g. myocardial infraction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening or occurring during the screening period)
•19. Planned elective surgery during the study period
•20. Life expectation less than 12 months
•21. Pregnancy or breast feeding
•22. Woman of childbearing potential without effective contraception
•23. Previous treatment with RO0503821
•24. Administration of another investigational drug within 4 weeks before screening or planned during the study period
•25. Know hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituents of the study or reference drug formulations

研究者

发起方

F Hoffmann-La Roche Ltd

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