NCT02648126Unknown4 期
Research of Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa Produced by Immunobiological Technology Institute (Bio-Manguinhos) From Oswaldo Cruz Foundation (Bio-Manguinhos / Fiocruz)
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)0 个研究点目标入组 531 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 531
- 主要终点
- Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies.
研究概览
简要总结
The purpose of this study is to determine occurrence of pure red cell aplasia in a group of participants with chronic renal insufficiency and with resistance criteria to epoetin alfa treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and it is provided by the Unified Health System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Use of alfa epoetin manufactured by Bio-Manguinhos for at least 8 weeks before the moment of hyporesponsiveness diagnosis;
- •Nonuse of alfa epoetin from another manufacturer for at least 24 weeks before hyporesponsiveness diagnosis;
- •Presence of the criteria for pure red cell aplasia disease, which is absence of a significant reduction in serum levels of leukocytes and platelets.
排除标准
- •The screened patients who have at least one of the following criteria will be excluded from the study, and it may be replaced by another participant for the research.
- •if there is no legal representative, an intellectual disability that restrain the compliance and signature of informed consent,
- •no agreement assigning the informed consent;
- •It will be excluded from the study if from the moment of hyporesponsiveness diagnosis the participant have: lactation pregnancy, hypersensitivity or intolerance previously known for alfa epoetin or one of its components, intolerance or allergy to parenteral iron, acute hemorrhage, kidney transplantation, hemolysis defined as the presence of anemia associated with high levels of indirect bilirubin and lactate dehydrogenase , percentage of reticulocytes> 1.5% absolute reticulocyte> 75,000 / microliter.
- •deficiency of folate and / or vitamin B
- •pancytopenia.
- •in use with medications known to cause anemia and / or pure red cell aplasia as: Valproic Acid; Azathioprine; Chloramphenicol; Phenytoin; Isoniazid; Mycophenolate mofetil.
- •presence of the following comorbidities: Diabetes mellitus; epilepsy; chronic viral hepatitis; secondary hyperparathyroidism uncontrolled; hypertension systolic; inflammation (acute or chronic); myelofibrosis; myelodysplasia; neoplasm and thalassemias;
- •severe disease in the 24 weeks before the hyporesponsiveness diagnosis; including: stroke, septic shock, thromboembolic events; acute myocardial infarction
- •lack of information or damage to quality data that avoid disease classification as a case of hyporesponsiveness.
- •Immunoglobulin M and Immunoglobulin M serology for Parvovirus B19, Epstein-Barr and Cytomegalovirus.
- •serology for HIV in the last 12 months.
- •established immunological disease.
- •dosage of protein C-reactive titrated .
- •presence of antinuclear antibody and rheumatoid factor.
结局指标
主要结局
Number of Participants With Hyporesponsiveness to EPO related to anti-alfa epoetin antibodies.
时间窗: 3 years
次要结局
- Hemoglobin levels related to alfa epoetin dosage(3 years)
- Percentage anti-alfa epoetin neutralizing antibodies related to Hemoglobin levels(3 years)
- Serum levels of leukocytes and platelets correlated with anti-alfa epoetin antibodies(3 years)
- Anti-alfa epoetin antibodies titers related to Hemoglobin levels(3 years)
研究者
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