EUCTR2004-000678-30-CZ进行中（未招募）1 期
An Evaluation of the Efficacy of Epo-Omega in Treatment of Anaemia in ESRD Patients When Administered by Thrice Weekly Intravenous Injection: A Dose Dependency Evaluation. - Epomax (3 x week i.v.) A dose dependency evaluation
相关药物
试验速览
- 阶段
- 1 期
- 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
入选标准
- •1. Patients who have provided written informed consent.
- •2. Patients with stable Hb <10.5g/dL (stable = at least two Hb measurements <10.5g/dL, a minimum of 7 days apart, in a 42 day period prior to formal screening for the study.
- •3. Haemodialysis 3X/W for a minimum of 3 months and with delivered Kt/V =1.20/session (renal clearance to be added to K in case of residual renal function (RRF) [urine volume >100mL] and renal urea clearance >0.5mL/min). In the case that Kt/V determinations are not possible, a urea reduction rate (URR) of > 65% will be accepted.
- •4. Patients 18-75 years of age (inclusive).
- •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 >100 mm Hg determined during two separate pre-dialysis measurements, preferably the second session of the week).
- •2.Patients with Vit B12 deficiency (<200 ng/L) or folic acid deficiency (<3.0µg/L).
- •3.Patients receiving treatment for cancer.
- •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 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 screening.
- •11.Patients with acute infection(s).
- •12.Patients with inflammatory status (CRP >30mg/L).
- •13.Patients with HIV.
- •14.Patients with chronic hepatitis C or chronic hepatitis B (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, mammalian cell line products or human serum albumin.
- •19.Patients with a history of pure red cell aplasia (any cause).
- •20.Patients with a serum albumin < 30 g/L.
- •21.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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