Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesions
Conditions
Interventions
None listed
Sponsors
INSTITUTIONAL RESEARCH FUND
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed cases of childhood onset nephrotic syndrome 2. Subjects willing to give written informed consent and comply with study related instructions
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactNILADRI SEKHAR DINGAL
IPGMER
Outcome results
None listed