Supervision of pediatric patients of childhood onset nephrotic syndrome on rituximab
Not Applicable
Completed
- Conditions
- Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesions
- Registration Number
- CTRI/2020/07/026555
- Lead Sponsor
- INSTITUTIONAL RESEARCH FUND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
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
Exclusion Criteria
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: 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
- Secondary Outcome Measures
Name Time Method TO CHECK IF ANY ADVERSE REACTION PRESENT OR NOTTimepoint: AT THE END OF 2 MONTHS, 4 MONTHS, 6 MONTHS, 9 MONTHS, 12 MONTHS, 15 MONTHS, 18 MONTHS