Article Text
PDF
Statistics from Altmetric.com
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 …
Footnotes
Contributors NS and ADL coauthored the abstract and commentary.
Provenance and peer review Not commissioned; internally peer reviewed.
Patient consent for publication Not required.
Request Permissions
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.