CTRI/2010/091/000652未知不适用
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, Maharashtra2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 待定
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 1. Change in Mean Haemoglobin level
研究概览
简要总结
This study is an interventional, prospective, randomized, observational study to evaluate the safety and efficacy of folic acid 2.5mg plus cyanocobalamin 2 mg plus pyridoxine (B6) 25 mg as adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in anaemia of End stage renal disease as compared to only r-HuEPO therapy.
研究设计
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
入选标准
- •Age 18 years and above
- •Subjects of either gender, males or females
- •Subject has given informed consent for participation in this trial.
- •Medically stable CRF patients.
- •Subject on stable EPO alpha therapy for at least 6 weeks at the time of enrolment.
- •Haemoglobin level ≥ 8 g/dL and ≤11g/dl
- •Given written informed consent for participating in the trial.
排除标准
- •Pregnant and nursing mothers
- •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
- •Subjects with iron deficiency anaemia (Defined as serum ferritin levels ≤ 100 μg/L, TSAT ≤ 20% and peripheral smear picture suggestive of iron deficiency anaemia)
- •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.
- •Subjects with history of sickle cell anemia, thalassemia or any other hemoglobinopathies.
- •Subjects with history of any significant medical disorder other than ESRD.
- •Subjects with history of malabsorption syndrome, sprue, fish tapeworm infection, pancreatitis and myeloproliferative disorders.
- •Subjects with history of gastrectomy, surgical blind loops or severe abnormalities in the terminal ileum, ileal resection, regional ileitis or intestinal lymphoma.
- •Subjects expected to receive blood transfusion in next 3 months.
- •Subjects with history of alcohol consumption > than 20 gm/week.
- •Subjects who are unwilling or unable to give informed consent.
结局指标
主要结局
1. Change in Mean Haemoglobin level
时间窗: 8/12 Weeks
次要结局
- 3) RBC folate assay(12 Weeks)
- 1) Red blood cell indices ( MCV, MCH, MCHC, RDW)(12 Weeks)
- 2) Serum vitamin B12 assay(12 Weeks)
- 4) Serum homocysteine(12 Weeks)
研究者
研究点 (2)
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