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Rituximab is more effective than tacrolimus in steroid-dependent nephrotic syndrome
  1. Nicole Solomon1,
  2. Alex D Lalayiannis2
  1. 1 Paediatric Nephrology, Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, UK
  2. 2 Paediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
  1. Correspondence to Dr Alex D Lalayiannis, Paediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London WC1N 3JH, UK; alex.lalayiannis{at}nhs.net

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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 …

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