EUCTR2004-000676-13-SK进行中（未招募）1 期
An Evaluation of the Efficacy of Epo-Omega in The Treatment of Anaemia in Chronic Kidney Disease (CKD) Patients When Administered by Once Weekly Subcutaneous Injection: A Dose Dependency Evaluation. - Epomax (1 x / week s.c.) A dose dependency evaluation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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.Patients who have provided written informed consent.
- •2.Patients with stable Hb <11.0g/dL (stable = at least two Hb measurements <11.0 g/dL, a minimum of 7 days apart, in a 42 day period prior to formal screening for the study AND then 3 Hb values taken at screening, in between the Screening Visit and Visit 0 (Day 1) and at Visit 0 (Day 1).
- •3.A glomerular filtration rate (GFR) of 15-59 ml/min/1.73m2 (stage 3-4, mild to moderate renal impairment) as determined using the Cockcroft-Gault formula.
- •4.Patients of 18 years of age and above.
- •5.Patients with an adequate iron status defined as serum ferritin =100µg/L and transferrin saturation =20% 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 uncontrolled hypertension (diastolic BP>100mm Hg determined on two separate occasions).
- •2.Patients with Vit B12 deficiency (<200 ng/L) or folic acid deficiency (<3.0µg/L).
- •3.Patients with a diagnosis of cancer (except skin cancer) currently under active treatment.
- •4.Patients with haemolytic anaemia or anaemia due to other diseases.
- •5.Patients with clinically persistent blood loss (e.g. gastrointestinal).
- •6.Patients with known epilepsy.
- •7.Patients with severe hyperparathyroidism with bone involvement and/or indication for parathyroidectomy.
- •8.Pregnant or lactating patients.
- •N.B. Female patients of childbearing potential must have a negative serum pregnancy test at the time of screening and will be required to use a medically acceptable means of contraception during their participation in this study.
- •9.Patients who have received Interferon or Ribavirin within 30 days prior to the Screening Visit.
- •10.Patients who have received Epoetin (Alpha, Beta) or Darbepoetin alfa treatment, androgens or transfusions within the last 90 days prior to the Screening Visit.
- •11.Patients with acute infection(s).
- •12.Patients with inflammatory status (CRP >30mg/L).
- •13.Patients with HIV.
- •14.Patients with biochemical evidence of significant liver disease (with transaminases >2X upper limit).
- •15. Patients who have received cytotoxic agents, immunosuppressives or radiation therapy within 30 days prior to the Screening Visit.
- •16.Patients participating in another interventional study.
- •17.Patients who have received investigational drug within 30 days prior to the Screening Visit.
- •18.Patients with known hypersensitivity to Epoetin, or mammalian cell line products or human serum albumin.
- •19.Patients with a history of pure red cell aplasia (any cause).
- •20.Patients with a history of anti-EPO antibodies.
- •21.Patients with a serum albumin < 30 g/L.
- •22.Patients with a life expectancy < 6 months.
- •Patients who have had a renal transplant are allowed to participate in the study, as are those who are on the transplant waiting list. Those who are scheduled to have a living related donor operation within the next 3 months must be excluded.
研究者
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