EUCTR2004-000673-57-AT进行中（未招募）不适用
Efficacy and Safety of Epoetin-Omega i.v. for Treatment of Anemia in Hemodialyzed Patients Hyporesponsive to a Previous Epoetin Beta i.v. Treatment: a Randomized, Parallel Group Trial. - Epomax Hyporesponsive patients 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
- 46
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
- •Potential candidates for enrolment will be selected based on a detailed medical history Chart Review. In addition, the potential patients, who have provided written consent, will then undergo a screening visit evaluation in order to confirm their eligibility for inclusion in the study.
- •In order for a patient to be considered as a potential candidate for enrolment, the following conditions must be verified by objective evidence during the Chart Review
- •Inclusion Criteria:
- •1. Patients have been adequately selected by the Chart Review.
- •2. Patients have provided written and signed informed consent.
- •3. Hb at the screening visit <11.0 g/dl.
- •4. Total Epoetin Beta dose delivered in the week between screening and day 1 visit is =200 IU/kg.
- •5. Delivered Kt/V >1.20 at the screening visit (renal clearance to be added to K in case of RRF (urine volume >100ml and renal urea clearance >0.5ml/min). In the case that the Kt/V determination is not possible, a URR of >65% at the screening visit will be accepted.
- •6. Patients with an adequate iron status defined as TSAT =20% and ferritin =100µgl at the screening visit.
- •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. Patients with a history of a hypertensive crisis within 8 weeks prior to the screening visit.
- •2. Patients with aluminium overload, defined as serum Al >60 µg/l (or 2.22 µmol/l) at the screening visit.
- •3. Patients with vitamin B12 deficiency (<200ng/l) or folic acid deficiency (<3.0µg/l) at the screening visit.
- •4. Patients suffering from cancer that cannot be considered as in remission”.
- •5. Patients whose life expectancy in the judgment of their physician is 6 months or less.
- •6. Patients with hemolytic anemia or anemia due to diseases other than ESRD (e.g., hemoglobinopathies, myelodisplasia etc.).7. Patients who have experienced a clinically relevant blood loss or hemolysis within 4 weeks prior to the screening visit.
- •8. Patients with known epilepsy.
- •9. Patients with hyperparathyroidism who have:
- •Verified osteitis fibrosa and/or indication for parathyroidectomy
- •iPTH >500 pg/ml at the screening visit and have not been treated for hyperparathyroidism
- •Undergone parathyroidectomy within 6 weeks prior to the screening visit
- •10. Pregnant or lactating patients.
- •NB: Female patients of childbearing potential must have a negative serum (or urine if appropriate) pregnancy test at the time of screening and will be required to use a medically acceptable means of contraception during their participation in the study. Women of childbearing potential are defined as women less than 55 years old who have not had a partial or full hysterectomy.
- •11. Patients with an acute infection / inflammation or an exacerbation of a chronic disease.
- •12. Patients with HIV.
- •13. Patients that received erythropoiesis stimulators (other than Epoetin Beta), such as androgens, cytotoxic agents, radiation treatment, high-dose immunosuppressants, interferon or ribavirin within 12 weeks prior to screening. Low-dose immunosuppressants, interferon, ribavirin and similar therapeutic agents that are used on chronic basis for the control of a chronic disease are acceptable.
- •14. Patients participating in another interventional study.
- •15. Patients who have received an investigational drug within 30 days prior to the screening visit.
- •16. Patients with known hypersensitivity to erythropietin or mammalian cell line products or human serum albumin.
- •17. Patients with a history of acquired pure red cell aplasia (PRCA) of any cause.
- •18. Patients with serum albumin < 30 g/l at the screening visit.
- •19. Patients with a history of anti-erythropoietin antibodies.
- •20. Patients scheduled for living donor renal transplant or other elective surgery within the next 6 months.
研究者
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