Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
Conditions
Interventions
Intervention1: Mycophenolate mofetil (MMF) as maintenance therapy after rituximab in steroid dependent or frequently relapsing nephrotic syndrome: Rituximab therapy (both groups): Two doses of rituxim
if depletion is inadequate, rituximab will be redosed until depletion is achieved.
Test group (Rituximab plus MMF): After completion of Rituximab infusion, MMF will be started at 600 mg per m per do
Sponsors
Dr. Subhankar Sarkar
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients aged 2 to 18 years with SDNS or FRNS who have either failed at least two steroid-sparing medications (levamisole, mycophenolate mofetil, cyclophosphamide, calcineurin inhibitors) within the past 12 months or have failed one steroid sparing agent and exhibit severe steroid toxicity (such as cataracts, glaucoma, or diabetes mellitus). ii. Normal eGFR (more than 60 ml per min per 1.73m2). iii. Legal guardian (at least one parent or guardian) willing to give informed written consent.
Exclusion criteria
Exclusion criteria: i. Prior therapy with Rituximab for any indication in the last two years. ii. Historical steroid resistance in the last one year. iii. HIV, Hepatitis B, and C serology positive (done in last 3 months). iv. Mantoux test positive v. Acute or chronic active infection; positive Mantoux (within last 2 years) and untreated. vi. Chronic lung disease or uncontrolled asthma at time of recruitment. vii. Leucopenia (WBC less than 4400 per cmm) or thrombocytopenia (Platelets less than 150,000 per cmm) at time of recruitment. viii. Transaminitis (SGOT or SGPT more than 2.5 times the UNL), chronic diarrhea at time of recruitment. ix. The participant is unlikely to follow protocol visit as perceived by the investigators. x. Prior history of allergy to MMF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the superiority of MMF as maintenance immunosuppressive therapy after Rituximab vs no maintenance therapy in increasing the proportion of patients achieving sustained remission at 12 months in children aged 2 18 years with steroid-dependent or frequently relapsing nephrotic syndrome who have failed at least two steroid-sparing agents.Timepoint: At 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first relapse 2. Proportion of patients having frequent relapses 3. Frequency of relapses 4. Relapse Rate 5. Cumulative prednisolone requirement 6. Frequency of hospitalization due to any reason 7. Proportion of patients experiencing therapy-associated adverse events (both solicited & unsolicited self-reported), including leucopenia, thrombocytopenia, infusion-related reactions (fever, chills, rash, bronchospasm, anaphylaxis), & acute lung injury (related to Rituximab) 8. Proportion of patients experiencing adverse effects related to MMF (cytopenia, transaminitis, gastrointestinal intolerance). 9. Any change in anthropometry (Z score of height for age; weight for age; body mass index in more than 5yrs age)Timepoint: At 18 months follow-up | — |
Countries
India
Contacts
Public ContactSubhankar Sarkar
AII India Institute of Medical Sciences, Kalyani
Outcome results
None listed