Single dose Rituximab in steroid dependent nephrotic syndrome and frequently relapsing nephrotic syndrome in children 2-18 years of age during a period of 1 year
Not Applicable
- Conditions
- Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
- Registration Number
- CTRI/2023/07/054906
- Lead Sponsor
- Jawaharlal Nehru Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children with Steroid dependent nephrotic syndrome and frequently relapsing nephrotic syndrome
Exclusion Criteria
Children with Steroid resistant nephrotic syndrome
Children with Chronic kidney disease
Children who have already received Rituximab within last 1 year
Children who are on Cyclosporin and on other calcineurin inhibitors
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess sustained remission at 3 months post single dose rituximab in patients with steroid dependent nephrotic syndrome & frequently relapsing nephrotic syndromeTimepoint: The study will be conducted over a span of one year
- Secondary Outcome Measures
Name Time Method To assess B cell suppression by measuring CD19 levels just prior to rituximab then at 3 weeks & 3 months post single dose rituximab <br/ ><br>To predict relapse by assessing for recovery of B cell at 3 weeks and at 3 months post single dose rituximabTimepoint: 1 year