EUCTR2005-000140-85-HU进行中（未招募）不适用
Efficacy and Safety of subcutaneous administration of XM01 and Epoetin beta for treatment of anaemia in chronic renal failure patients not yet receiving dialysis. A multinational, multicentre, randomised, controlled, double-blind, parallel group phase II study.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Patients of any ethnic origin meeting all criteria listed below will be included in the study:
- •1. Above 21 years of age (inclusive).
- •2. Male or female sex.
- •3. Patients with chronic renal failure not yet receiving dialysis and having a glomerular filtration rate (GFR) < 60 mL/min/1.73 m3 within the last 3 months (estimated by Cockroft-Gault formula)
- •4. Patients who have not been treated with epoetin within the last 12 weeks or with epoetins with a longer half-life time (e.g. Darbepoetin alfa, continuous erythropoiesis receptor activator [CERA]) within the last 6 months.
- •5. Stable haemoglobin (at least three measurements within the last 8 weeks prior to randomisation, the difference between the highest and lowest value should be less than 2 g/dL).
- •6. Haemoglobin = 10.0 g/dL (mean value of three measurements within the last 8 weeks, separated from each other by at least one week).
- •7. Serum ferritin >100 mg/L and transferrin saturation (TSAT) >20% (within the last 4 weeks prior to randomisation).
- •8. Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
- •9. Written informed consent to participate in the study after receiving adequate previous information.
- •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
- •Patients presenting with any of the following will not be included in the study:
- •1. Female patients of childbearing potential.
- •2. Patients requiring red blood cell transfusions.
- •3. Red blood cell transfusion within the last 8 weeks.
- •4. Uncontrolled severe hypertension defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg
- •5. History of myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 6 months prior to enrolment.
- •6. Congestive heart failure (New York Heart Association [NYHA] class 3 or 4).
- •7. Uncontrolled diabetes mellitus defined as HbA1c >8.0%.
- •8. Patients with known liver disease, or
- •elevated serum transaminase (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal (ULN).
- •(Comment: Hepatitis B-virus surface antigen (HBsAg) carrier status or positive antibodies to hepatitis C virus (HCV) per se is not defined as an exclusion criterion if transaminases are within the normal range).
- •9. Severe metabolic acidosis (bicarbonate <18 mEq/L [<18 mmol/L]).
- •10. Tertiary or poorly controlled secondary hyperparathyroidism defined as intact parathyroid hormone (PTH) = 10 times the ULN.
- •11. Severe endogenous depression or schizophrenia.
- •12. Current malignant disease.
- •13. Known bone marrow disease.
- •14. Current systemic infection or inflammatory disease.
- •15. Any cause for anaemia other than chronic renal failure.
- •16. Deficiency of vitamin B12 and/or folic acid (i.e. below lower limit of reference range)
- •17. Known to test positive for human immunodeficiency virus antibodies.
- •18. Concomitant therapy with immunosuppressive drugs or androgens or steroids (oral or intravenous).
- •19. Therapy with androgens within the last 3 months.
- •20. Patients with known hypersensitivity (drug intolerance or allergy) to Epoetin or excipients of the formulation.
- •21. Known presence of antibodies to Epoetin.
- •22. Known or suspected drug abuse or alcohol abuse.
- •23. Participation in a study with investigational drugs within 30 days prior to enrolment.
- •24. Planned travel activities outside the participating countries during the study.
- •Patients may be enrolled into this study more than once only in case the inclusion criteria Nos. 5, 6 or 7 are not fulfilled or the exclusion criterion No. 16 is fulfilled during the screening period.
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