Active Safety surveillance study in pediatric patients of Childhood onset Nephrotic Syndrome on Rituximab therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Since this is an active surveillance study in addition to clinical assessment variables and investigations advised by the attending clinician, the complete blood count and CD20 count will be evaluated by flow cytometry prior to administration of first dose and 8 weeks after completion of first course of therapy or earlier as advised by the attending clinician.
研究概览
简要总结
this is an active safety surveilence study on childhood onset nephrotic syndrome who are recieving rituximab as treatment. our main focus is to locate any adverse reaction following rituximab. Diagnosed cases of childhood onset nephrotic syndrome (CONS)who are refractory to conventional firstand second line immunosuppressant therapy attending the nephrology/ pediatricsOPD/ IPD of this hospital shall be screened.Eligible subjects shall be categorized as two cohorts-
(1) RTX treatment naïve cohort- those who have been advised RTX and shallreceive the first dose in our hospital.
(2) RTX treated cohort: those who have been administered at least onedose of RTX in the last 3 months from our hospital.
All enrolled subjects shall be actively followedup every 2 months for the first 6 months and thereafter every 3 months upto 12 monthsfrom the date of initiation of RTX therapy for all suspected RTX induced ADR. Estimationof CD20 count by flow cytometry will be done at the department of Pharmacologyand all other investigations as advised by the attending clinician required forestablishing causal association of the suspected adverse reaction to rituximabshall be done form our hospital and recorded. The study isintended to be completed within a period of eighteen months from initiation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosed cases of childhood onset nephrotic syndrome ≤18 years of age, of any gender, who have either received at least one dose of RTX in the last 3 months or shall receive rituximab in our hospital.
- •2.Subjects willing to give written informed consent and comply with study related instructions.
排除标准
- •1.Subjects unwilling to give written informed consent and comply with study related instructions.
- •2.Subjects on rituximab therapy for any non-renal indications.
- •3.Subjects who have received the last dose of RTX more than 3 months back.
结局指标
主要结局
Since this is an active surveillance study in addition to clinical assessment variables and investigations advised by the attending clinician, the complete blood count and CD20 count will be evaluated by flow cytometry prior to administration of first dose and 8 weeks after completion of first course of therapy or earlier as advised by the attending clinician.
时间窗: All enrolled subjects shall be actively followed up every 2 months for the first 6 months and thereafter every 3 months upto 12 months from the date of initiation of RTX therapy for all suspected RTX induced ADR
次要结局
- TO CHECK IF ANY ADVERSE REACTION PRESENT OR NOT(AT THE END OF 2 MONTHS, 4 MONTHS, 6 MONTHS, 9 MONTHS, 12 MONTHS, 15 MONTHS, 18 MONTHS)