EUCTR2006-004032-75-DE进行中（未招募）不适用
An open-label, multi-center study to demonstrate the efficacy and safety of C.E.R.A when administered intravenously with pre-filled syringes (PFS) for the treatment of anemia in patients with chronic kidney disease who are on dialysis previously receiving subcutaneous or intravenous epoetin alfa or beta or darbepoetin alfa treatment - MIRACE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •2. Adult patients (18 years and older) with chronic renal anemia
- •3. Regular long-term hemodialysis with the same mode of dialysis for at least
- •12 weeks before screening phase
- •4. Kt/V 1.2 or greater or urea reduction of > 65%
- •5. Baseline hemoglobin concentration between 10 and 13 g/dl
- •6. Weekly iv or sc dosis of epoetin alfa, beta or delta 4000 – 10000 IU or weekly iv
- •or sc dosis of darbepoetin alfa 20 – 50 µg (or of darbepoetin alfa is used in longer
- •intervals a dosing matching the given weekly dose)
- •7. Intravenous or subcutaneous maintenance epoetin alfa, beta or delta or
- •darbepoetin
- •alfa therapy with the same dosing interval (i.e., one, two or three times weekly or
- •every second week) for at least 4 weeks before the screening phase.
- •8. Adequate iron status defined as serum ferritin 100 ng/mL or more or TSAT within
- •Lab normal values within 4 weeks prior to study start and confirmed during
- •screening pahse.
- •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. Relevant acute or chronic bleeding i.e. requiring therapy within 8 weeks prior to
- •screening e.g. overt gastrointestinal bleeding
- •2. RBC transfusions within 8 weeks before screening phase
- •3. Patients who are on dialysis due to graft failure unless the graft is removed
- •4. Change in hemoglobin concentration = 2 g/dl during the 2 months screening
- •period or hemoglobin out of range (10-13 g/dl) during screening phase if confirmed
- •within 2 weeks
- •5. Weekly iv or sc dosis of epoetin alfa, beta or delta < 4000 or >10000 IU or
- •weekly iv or sc dosis of darbepoetin alfa < 20 or > 50 µg at study
- •start or respective dose if not administered weekly
- •6. Change in frequency, route of administration or medication in therapy with
- •epoetin alfa, beta or delta or darbepoetin alfa, respectively, during the screening
- •7. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all
- •8. Hemolysis haptoglobin < 30 mg/dl (3,54 µmol/l) or other reliable positive test of
- •9. Active malignant disease (except non-melanoma skin cancer)
- •10. Vitamin B12 deficiency during screening phase
- •11. Folic acid deficiency during screening phase
- •12. Uncontrolled or symptomatic secondary hyperparathyroidism
- •13. Poorly controlled hypertension (diastolic BP > 100) or interruption of epoetin
- •alfa, beta or delta or darbepoetin alfa treatment due to high BP in the 6 months
- •before screening phase
- •14. Epileptic seizure in the 6 months before screening-phase
- •15. acute or chronic systemic inflammatory disease
- •16. Myocardial infarction or stroke within 12 weeks before screening.
- •17. Severe or unstable coronary artery disease
- •18. Severe liver disease
- •19. Platelets > 500 x 10 9/L or < 100 x 10 9 /l at the beginning of screening phase
- •20. Confirmed Pure red cell aplasia (PRCA) or suspected PRCA
- •21. Chronic congestive heart failure (New York Heart Association Class IV)
- •22. Planned elective surgery during the study period except for cataract surgery
- •23. Life expectancy less than 12 months
- •24. Pregnancy or lactation period
- •25. Women of childbearing potential without effective method of contraception
- •(effective means less than 1% failure rate per year)
- •26. Previous treatment with C.E.R.A
- •27. Administration of another investigational drug within 4 weeks or 7 half-lifes of
- •the IMP, whatever longer, before start of study
- •28. Known hypersensitivity to recombinant human erythropoietin, polyethylene
- •glycol or to any constituent of the study drug formulations
- •29. Temporary dialysis access catheter (e.g. Shaldon Catheter)
- •30. Underage Patients or patients who are not able to understand the meaning of
- •this clinical trial (according to §40 Abs. 4 and §41 Abs. 2 and Abs. 3 AMG)
- •31. Patients who have been enrolled in this trial before
- •32. Known psychological disease, which can inhibit the patient to fully understand
- •the meaning of the study
- •33. Persons who are possibly dependent from sponsor and/or investigator
研究者
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