EUCTR2011-005058-70-SK进行中（未招募）1 期
A phase III, randomized, open-label, active-controlled, multicenter, correction phase study of the efficacy, safety, pharmacokinetics, and pharmacodynamics of APO-EPO (epoetin alfa) as compared to Epogen®/Procrit® when given subcutaneously to patients with anemia and chronic kidney disease not yet on hemodialysis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- APOTEX Inc.
- 入组人数
- 196
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
- •1. Written informed consent of the patient;
- •2. Hb level <10 g/dl;
- •3. Age: = 18 years, male or female patients;
- •4. Patients suffering from chronic renal failure (CRF) not yet undergoing dialysis, with glomerular filtration rate (GFR) below 30 ml/min calculated from the plasma creatinine using the Cockroft-Gault formula;
- •5. Epoetin-naïve patients;
- •6. CRF patients with estimated time to progression to ESRF (end stage renal failure) of 8-12 months as estimated by the Reciprocal creatinine vs time plot” method;
- •7. Serum ferritin level = 100 ng/ml and transferrin saturation = 20% prior to entry into the correction phase of the study;
- •8. Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
- •9. Females of childbearing potential agree to practice an acceptable method of birth control (e.g. abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Patients on regular hemodialysis or peritoneal dialysis;
- •2. C-Reactive protein (CRP) > 10 mg/l, as measured with a standard method;
- •3. Uncontrolled hypertension (defined as diastolic blood pressure = 100 mmHg or systolic blood pressure = 180 mmHg);
- •4. Primary hematological disorder (e.g. myelodysplastic syndrome, multiple myeloma, sickle cell anemia, hematological malignancy, hemolytic anemia);
- •5. Decompensated liver failure;
- •6. Clinical evidence of concurrent uncontrolled hyperparathyroidism defined as serum parathyroid hormone (PTH) > 1000 pg/ml;
- •7. Previous stroke or evident disturbances of brain blood flow, e.g. transient ischemic attack (TIA);
- •8. Hypothyroidism without adequate replacement therapy (adequate defined as stable dose with stable thyroid hormone levels for at least 3 months prior to Screening);
- •9. Any red blood cell transfusion during the last 3 months (measured at the time of eligibility verification);
- •10. Heart failure [New York Heart Association (NYHA) class III and IV]
- •11. Unstable angina pectoris, active cardiac disease, stroke and/or myocardial infarction within the last six months prior to screening;
- •12. History of or active blood coagulation disease;
- •13. Thrombocytosis (platelet count > 500,000/µl);
- •14. Thrombocytopenia (platelet count < 100,000/µl);
- •15. Leukopenia (white blood cell count < 2,000/µl);
- •16. History of phenylketonuria;
- •17. Deficiency in vitamin B12 (if not corrected during the 6-week-anemia-work-up period);
- •18. Deficiency in folic acid (if not corrected during the 6-week-anemia- work-up period);
- •19. Overt bleeding (acute or chronic bleeding within the last two months prior to screening);
- •20. Suspicion of or confirmed occult bleeding (increased reticulocyte count);
- •21. Clinical evidence of concurrent systemic infection or inflammatory disease;
- •22. Presence of neutralizing antibodies or suspicion of or known pure red cell aplasia (PRCA);
- •23. Currently receiving treatment for epilepsy;
- •24. Major surgery within the last six months prior to Screening and during the conduct of the trial;
- •25. Proven HIV, HBV or HCV infection (to be tested if no test was performed within four weeks prior to the screening);
- •26. Any androgen therapy within the last two months prior to screening and during the study;
- •27. Concomitant immunosuppressive therapy; patients on a short course of steroids (e.g. treatment of a gout attack), topical or intranasal steroids are allowed in the study;
- •28. History of malignant disease within the last 5 years prior to Screening;
- •29. Pregnant or breastfeeding women;
- •30. Known history of severe drug-related allergies;
- •31. Known allergy to one of the ingredients of the test or reference product (including the preservative used for the multi-dose IP) or Venofer or hypersensitivity to mammalian-derived products;
- •32. Transplant received within 48 weeks prior to study entry;
- •33. Simultaneous participation in another clinical study or participation in a study within 3 months before randomization;
- •34. Psychiatric, addictive (drugs or alcohol), or any other disorder that compromises the ability to give an informed consent;
- •35. Any other condition which at the investigator’s opinion may put the patient at risk or may confound the study results.
研究者
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