An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Recombinant Erythropoietins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,670
- 主要终点
- Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies Development Associated With Different Routes of Administration
研究概览
简要总结
The purpose of this study is to record the number of participants with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.
详细描述
This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) and cohort study. Study specific information will be collected from participants with chronic renal disease who are receiving recombinant erythropoietin and their treatment course will be followed for up to 2 years and participants will not receive any intervention in this study. Upon entering the study, information will be collected regarding disease history and recombinant erythropoietin treatment. Every 3 months thereafter, progress information will be collected, including recombinant erythropoietin treatment, number of red blood cells and presence of any signs of pure red cell aplasia (PRCA) development. The results of this study will be combined with a similar study (EPO-IMU-402) that also collects blood samples to observe the number of patients who develop antibodies to erythropoietin. Participants discontinuing erythropoietin will be followed only for an additional 12 months from the time erythropoietin is discontinued. Participants will receive standard-of-care treatment for their chronic renal disease from their individual Investigators. Participants will be primarily observed prospectively for PRCA. The study hypothesis is that these data will provide a framework for the expansion of the patient population to estimate the incidence of PRCA associated with the use of epoetin alfa or other recombinant erythropoietins for other therapeutic indications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients of legal age to give consent according to local standards
- •Patients must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease
- •Physicians treating the patients must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)
- •If required by local ethics committees, patients must give consent to permit the collection of de-identified personal data for the specific purpose of this study
排除标准
- •Patients who are unable to complete future follow-up visits
- •Patients who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination
- •Patients with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
- •Patients whose anemia did not respond to previous treatment with an erythropoietin
- •Patients with a history of antibodies to erythropoietin prior to entering the study
结局指标
主要结局
Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies Development Associated With Different Routes of Administration
时间窗: Up to 2 years
Antibodies are immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the antigen (or a very similar shape) that induced their synthesis in cells of the lymphoid series.
Relationship between EPO Antibodies and PRCA
时间窗: Up to 2 years
Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.
Number of Participants With Pure Red Cell Aplasia (PRCA)
时间窗: Up to 2 years
The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
次要结局
- Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration(Every 3 Months up to up to 2 years)
- Change From Baseline in Number of Participants With PRCA Over Time(Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24)
- Number of Participants With Pure Red Cell Aplasia (PRCA) and non-PRCA(Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24)