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Study comparing two drugs Rituximab and Mycophenolate Mofetil in children with Steroid Resistant Nephrotic Syndrome whose disease is not controlled completely in spite of 2 years of drugs called Calcineurin Inhibitors - Cyclosporine and Tacrolimus

Efficacy of IV rituximab versus oral mycophenolate mofetil in sustaining remission in steroid resistant nephrotic syndrome maintained on calcineurin inhibitors for more than two years: An open-label non-inferiority randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023281
Enrollment
30
Registered
2020-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes

Interventions

Intervention1: IV Rituximab, Oral Mycophenolate Mofetil: IV Rituximab at 375 mg/m², given as infusion over 4-6 hours following premedication with hydrocortisone, diphenhydramine and paracetamol, as o

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) Age 5 - 18 years (2) Idiopathic steroid resistant NS, initial or late resistance (3) Minimal change disease or focal segmental glomerulosclerosis (4) Therapy with either CNI (cyclosporine or tacrolimus) for two years or longer (5) Complete or partial remission during therapy with calcineurin inhibitors (6) Infrequent or frequent steroid sensitive relapses during therapy with calcineurin inhibitors

Exclusion criteria

Exclusion criteria: (1) Nephrotic syndrome secondary to systemic disease or infection (2) Therapy with rituximab or mycophenolate mofetil in the last two years (3) Inability to swallow tablets or capsules of mycophenolate mofetil (4) Chronic infection with hepatitis B or C or human immunodeficiency virus (5) Impaired renal function, as indicated by eGFR (6) Leukopenia, neutropenia, thrombocytopenia, elevated hepatic transaminases or hypogammaglobulinemia

Design outcomes

Primary

MeasureTime frame
Proportion with satisfactory outcome i.e. Complete or partial remission with or without infrequent steroid sensitive relapsesTimepoint: At the end of 12 months of the start of study—

Secondary

MeasureTime frame
1. The proportion of patients with treatment failure 2. Frequency of relapses 3. Time to first relapse 4. Time to treatment failure 5. Cumulative prednisolone received 6. Frequency, severity and nature of adverse events, including SAE 7. Changes in height and BMI (body mass index) standard deviation scores (SDS) 8. Change in estimated glomerular filtration rate from baselineTimepoint: One year from the start of the study—

Countries

India

Contacts

Public ContactDr Sukanya Priyadarshini

All India Institute of Medical Sciences, New Delhi

aditisinhaaiims@gmail.com011-26546788

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026