A study to compare effectiveness for preventing disease recurrence and safety regarding drug related side effects between a newer-safe drug(Rituximab) and conventionally used drug(Calcineurin Inhibitors)in children with difficult to treat nephrotic syndrome, a chronic protein losing kidney disease.

Efficacy and Safety of Rituximab to that of Calcineurin Inhibitors in Children with Steroid Resistant Nephrotic Syndrome

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005364

Enrollment

120

Registered

2015-01-07

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: null- Nephrotic Syndrome

Interventions

Intervention1: Rituximab: Two to four rituximab infusions (over 2-4 weeks) will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2)depending on circulating

Eligibility

Inclusion criteria

Inclusion criteria: • Children between 3 and 16 years with SRNS • Minimal Change disease/MesPGN/FSGS as per Kidney Biopsy report. • Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2 at study entry. • Not received any steroid sparing agent previously. • Parents willing to give informed written consent. • Ability to swallow tablet

Exclusion criteria

Exclusion criteria: • Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS) • Patients with severe leucopenia (leucocytes 50 IU/L ) at enrolment. • Known active chronic infection (tuberculosis, HIV, hepatitis B or C) • Live vaccination within 1 mo.

Design outcomes

Primary

Measure	Time frame
12-month relapse-free survival in the intention-to-treat population.Timepoint: 3,6,9 and 12 month	—

Secondary

Measure	Time frame
â?¢ Frequency of relapses â?¢ Time to first relapse â?¢ Number of children achieved partial remission during study period â?¢ Number of children with treatment failure â?¢ Cumulative prednisolone dosage (mg/kg/year). â?¢ Drug related side effects. Timepoint: number of relapses at 3,6,9 and 12 month	—

Countries

India

Contacts

Public ContactBiswanath Basu

NRS Medical College and Hospital

basuv3000@gmail.com3323453245

Outcome results

None listed

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