CTRI/2010/091/000652招募中未知
A multicentre, prospective, randomized, study to evaluate the efficacy and safety of folic acid 2.5mg plus cyanocobalamin 2 mg plus pyridoxine (B6) 25 mg as an adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in patients with anaemia of End stage renal disease (ESRD).
Dr Narendra DedhiaParakh HospitalGhatkopar(E)Mumbai - 400 077, Maharashtra0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18 years and above
- •2. Subjects of either gender, males or females
- •3. Subject has given informed consent for participation in this trial.
- •4. Medically stable CRF patients.
- •5. Subject on stable EPO alpha therapy for at least 6 weeks at the time of enrolment.
- •6. Haemoglobin level ≥ 8 g/dL and ≤11g/dl
- •7. Given written informed consent for participating in the trial.
排除标准
- •1. Pregnant and nursing mothers
- •2. Subjects with history of macrocytic anemia secondary to liver disorder (ALT/AST > 2.5 times UNL or bilirubin > 2 times UNL), hypothyroidism and bone marrow disorders
- •3. Subjects with iron deficiency anaemia (Defined as serum ferritin levels ≤ 100 μg/L, TSAT ≤ 20% and peripheral smear picture suggestive of iron deficiency anaemia)
- •4. Subject on treatment with any of the study drug component. (i.e. folic acid, cyanocobalamin or pyridoxine (B6)), in such case wash out of 1 week will be necessary.
- •5. Subjects with history of sickle cell anemia, thalassemia or any other hemoglobinopathies.
- •6. Subjects with history of any significant medical disorder other than ESRD.
- •7. Subjects with history of malabsorption syndrome, sprue, fish tapeworm infection, pancreatitis and myeloproliferative disorders.
- •8. Subjects with history of gastrectomy, surgical blind loops or severe abnormalities in the terminal ileum, ileal resection, regional ileitis or intestinal lymphoma.
- •9. Subjects expected to receive blood transfusion in next 3 months.
- •10. Subjects with history of alcohol consumption > than 20 gm/week.
- •11. Subjects who are unwilling or unable to give informed consent.
研究者
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