NCT01184495已完成3 期
Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Hemoglobin Level in blood
研究概览
简要总结
A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We included adult patients with chronic renal failure on hemodialysis for more than three months at the Dialysis Unit of the Department of Nephrology, HCPA and the Center for Dialysis and Transplant (CDT), characterized as as patients on chronic regular dialysis procedure. Patients already in use of EPO for at least three months, only those taking the drug by subcutaneous and agreed to participate in the study.
- •Patients using different doses of EPO were included, but these were distributed across the treatment groups by randomization stratum dose of EPO, to ensure even distribution of patients in both groups.
- •It was considered that patients with HIV or AIDS who were in treatment for the disease with proper clinical management would be eligible for the study (as exemplified by patients with HIV or AIDS approved for inclusion on the waiting list for cadaveric kidney transplantation) .
- •Patients with a history of cancer or already treated in the oncological standpoint, and no signs of disease activity could be included.
排除标准
- •Patients who had other causes of anemia defined for maintenance, for example, patients with liver cirrhosis, with a history of gastrointestinal bleeding, patients with chronic Gastro Intestinal, Genital or Urinary bleeding or other sites were excluded. Similarly patients with AIDS without treatment, hemolytic anemia, pancytopenia, thalassemia, sickle cell anemia, myelodysplasia, multiple myeloma or other cancers or inflammatory arthritis. There was also no inclusion of patients with intolerance or allergy to iron parenterally, patients without adherence to dialysis or with chronic inadequate dialysis blood flow of vascular access persistently below 250 mL / min, kt / v, as a measure of efficiency of hemodialysis, persistently <1.2) or frequent hospitalizations considered as possible causes of inadequate response to erythropoietin.
- •We excluded patients with mental illness or condition that prevents the free consent and signature of informed consent, as well as previous reports of serious adverse effects to the drugs studied.
- •Criteria for withdrawal from the clinical trial: a view of the high morbidity of hemodialysis patients, expressed by frequent hospital clinics, it was found that patients in the study would not be withdrawn from the study due to hospitalization, provided that: the hospital did not involve surgery (except vascular access surgery or hospitalization in the intensive care unit or equivalent, or that represent otherwise, a loss of patient follow-up or co-interventions in the treatment of anemia of these).
- •Were withdrawn from the study patients who required blood transfusion because they have severe anemia or intervention unrelated to the usual treatment of anemia in hemodialysis patients.
研究组 & 干预措施
Epoetin Bio-Manguinhos
Experimental
干预措施: Epoetin Alfa-BioManguinhos (Drug)
EPO-BioSimilar
Active Comparator
Subcutaneous administration of EPO-BioSimilar
干预措施: Epoetin Alfa-BioSimilar (Drug)
结局指标
主要结局
Hemoglobin Level in blood
时间窗: Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months
The evaluation of the efficacy between different formulations of recombinant EPO: the one produced by Bio-Manguinhos and produced by private industry was observed in response to EPO as measured by levels of hemoglobin (Hb) results. The mean Hb of the two groups were compared, as well as the variation observed in both groups over time follow-up (six months).
次要结局
- Safety(Monthly assessment of adverse events)
研究者
Paulo Dornelles Picon
MhD
Hospital de Clinicas de Porto Alegre
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