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 loosing kidney disease.

Randomized Clinical Trial to Compare Efficacy and Safety of Rituximab to That of Calcineurin Inhibitor in Children With Steroid Dependent Nephrotic Syndrome - RITURNS (rituximab for relapse prevention in nephrotic syndrome)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/01/004355

Enrollment

Registered

2014-01-28

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 infusions will be administered intravenously at a 7-day interval at standard dose (rituximab 375mg/m2, maximum 500mg). Circulating B cells will be measured 24 hours after

Eligibility

Inclusion criteria

Inclusion criteria: Children between 3 and 16 years with SDNS Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report. Estimated glomerular filtration rate(eGFR) more than 80 ml/min per 1.73 m2 at study entry. Remission at study entry (trace or nil proteinuria, as determined by the dipstick test or less than 100 mg/dl for at least 3 days). Not received any steroid sparing agent previously. Parents willing to give informed written and audiovisual 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 less than 3.0Ã? 1000 cells/mm3), severe anemia (haemoglobin less than 8.9 g/dl), thrombocytopenia (platelet less than 100.0 Ã? 1000 cells/mm3) or deranged liver function tests (AST or ALT to more than 50 IU/L ) at enrolment. Known active chronic infection (tuberculosis, HIV, hepatitis B or C)

Design outcomes

Primary

Measure	Time frame
12-month relapse-free survivalTimepoint: 12	—

Secondary

Measure	Time frame
eGFR at 3, 6, 9 and 12 months, respectively. Amount of cumulative prednisolone requirement (mg/kg/yr) over 12 months Number of relapses within months 0-12, 0-6 and 7-12. Number of different steroid toxicity events (new onset) within month 0-12 Time to first relapse Fraction of patients off steroids at month 12 Abnormal values in biochemical tests and haematology assessments. Changes in Height sds and BMI sds from baseline to 12 months. Timepoint: 6,12	—

Measure

Time frame

eGFR at 3, 6, 9 and 12 months, respectively. Amount of cumulative prednisolone requirement (mg/kg/yr) over 12 months Number of relapses within months 0-12, 0-6 and 7-12. Number of different steroid toxicity events (new onset) within month 0-12 Time to first relapse Fraction of patients off steroids at month 12 Abnormal values in biochemical tests and haematology assessments. Changes in Height sds and BMI sds from baseline to 12 months. Timepoint: 6,12

—

Countries

India

Contacts

Public ContactBiswanath Basu

NRS Medical College and Hospital

basuv3000@gmail.com913323453245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026