Study design

Design: Single-centre, open-label, two parallel-arm phase 3 randomised comparative study.1

Allocation: All consecutive eligible patients were randomly allocated to receive either rituximab or tacrolimus along with alternate-day prednisolone over a 12-month period.

Blinding: Blinding was not undertaken.

Study question

Setting: Patients were recruited from a single centre in Sealdah, Kolkata, India.

Patients: All patients aged 3–16 years with steroid-dependent nephrotic syndrome (SDNS) attending the study centre with estimated glomerular filtration rate >80 mL/min/1.73 m². The participants were in remission with no proteinuria and no previous exposure to a corticosteroid sparing agent, and a secondary form of nephrotic syndrome and active infection had been excluded. All participants had a kidney biopsy 3 months prior to enrolment.

Intervention: Following randomisation, children received either oral tacrolimus for 12 months or a course of rituximab infusions:

Tacrolimus: 0.2 mg/kg/day (target trough levels of 5–7 ng/mL).

Rituximab: Two to …