Study comparing two medications, namely injection rituximab and oral tablets of mycophenolate mofetil, in controlling the disease in patients with steroid resistant nephrotic syndrome who have had a relapsing illness during therapy with calcineurin inhibitors for more than two years

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 randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046890

Enrollment

130

Registered

2022-10-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality Health Condition 2: N041- Nephrotic syndrome with focal andsegmental glomerular lesions

Interventions

Intervention1: Rituximab: Three doses of rituximab shall be given intravenously at a dose of 375 mg/ square meter body surface area, one each at 0, 1 and 26 weeks Control Intervention1: Mycophenolate

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 calcineurin inhibitor (CNI, cyclosporine or tacrolimus) for two years or longer (5) Complete or partial remission during therapy with CNI (6) Infrequent or frequent steroid sensitive relapses during therapy with CNI

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

Measure	Time frame
The proportion of patients with satisfactory remission, defined as complete or partial remission with or without infrequent steroid sensitive relapsesTimepoint: 12-months	—

Secondary

Measure	Time frame
The proportion of patients with treatment failure, defined as occurrence of any of the following: frequent steroid sensitive relapses, recurrence of steroid resistance, any serious adverse event (SAE) related to the intervention, or two or more SAE related to diseaseTimepoint: 12-months;Frequency of relapsesTimepoint: 12-months;Time to first relapseTimepoint: 12-months;Time to treatment failureTimepoint: 12-months;Cumulative prednisolone receivedTimepoint: 12-months;Frequency, severity and nature of adverse events, including causality assessment in relation to therapy and/or diseaseTimepoint: 12-months;Change in estimated glomerular filtration rate (eGFR)Timepoint: 12-months;Changes in height and BMI (body mass index) standard deviation scores (SDS)Timepoint: 12-months	—

Measure

Time frame

The proportion of patients with treatment failure, defined as occurrence of any of the following: frequent steroid sensitive relapses, recurrence of steroid resistance, any serious adverse event (SAE) related to the intervention, or two or more SAE related to diseaseTimepoint: 12-months;Frequency of relapsesTimepoint: 12-months;Time to first relapseTimepoint: 12-months;Time to treatment failureTimepoint: 12-months;Cumulative prednisolone receivedTimepoint: 12-months;Frequency, severity and nature of adverse events, including causality assessment in relation to therapy and/or diseaseTimepoint: 12-months;Change in estimated glomerular filtration rate (eGFR)Timepoint: 12-months;Changes in height and BMI (body mass index) standard deviation scores (SDS)Timepoint: 12-months

—

Countries

India

Contacts

Public ContactAditi Sinha

All India Institute of Medical Sciences

aditisinhaaiims@gmail.com9899145489

Outcome results

None listed

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