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. 2024 Aug 22;2024(8):CD001533. doi: 10.1002/14651858.CD001533.pub7

Raman 2016.

Study characteristics
Methods Study design
  • Parallel RCT

  • Time frame: March 2014 to July 2015

  • Follow‐up: 6 months

  • Country: India

  • Setting: single centre

Participants Study characteristics
  • Inclusion criteria: children with SSNS, treated with prednisone for first time or following relapse (includes frequent and infrequent relapsers)

  • Exclusion criteria: infants; secondary nephrotic syndrome; children with BSA > 1 m2 and weight > 30 kg; active infection


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (44/50); intervention group 2 (42/50)

  • Mean age (years): intervention group 1 (5.4 ± 2.9); intervention group 2 (5.2 ± 2.5)

  • Sex (M/F): intervention group 1 (27/13); intervention group (27/13)

Interventions Intervention group 1 (Body weight‐based)
  • Prednisolone: 2 mg/kg/day (maximum 60 mg) in two divided doses for 6 weeks, 1.5 mg/kg (maximum 40 mg) on alternate days for 6 weeks


Intervention group 2 (BSA‐based)
  • Prednisolone: 60 mg/m2/day (maximum 60 mg) in 2 divided doses for 6 weeks, 40 mg/m2 alternate days for 6 weeks

Outcomes Outcomes relevant to this review
  • Time taken for remission

  • Number of relapses

  • Cumulative dose of prednisolone

  • Adverse effects

Notes Additional information
  • The median cumulative dose of prednisone was 81 mg/kg (IQR 30 to 115) in the body weight‐based group and 96 mg/kg (IQR 36 to 130) in the BSA group

  • Funding source: supported, in part, by institutional and departmental funds

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk QUOTE: "Block randomization using 20 blocks of two block sizes (4 and 6) was generated using random allocation software version 2.0 (Informer Technologies, Inc.) to allocate the enrolled subjects into one of two groups (BW‐based or BSA‐based prednisolone regimen) in an allocation ratio of 1:1 by a person not directly involved with data collection, analysis or interpretation. This randomization list was concealed from the investigators carrying out the study"
Allocation concealment (selection bias) Low risk QUOTE: "Allocation was concealed placing individual assignments (folded twice) in serially numbered, sealed opaque envelopes by a person not involved in the trial"
Blinding of participants and personnel (performance bias)
All outcomes High risk Clinicians not blinded but statistician was blinded to treatment groups
Blinding of outcome assessment (detection bias)
All outcomes High risk QUOTE: The clinicians were not blinded but "the statistician was blinded to the assigned interventions until initial analysis and preparation of the first draft of manuscript"
Incomplete outcome data (attrition bias)
All outcomes Low risk 44/49 analysed for primary outcome. 7/100 (7%) not analysed
Selective reporting (reporting bias) High risk Outcomes presented as medians with ranges and not able to add to meta‐ analyses
Other bias Unclear risk Insufficient information to permit judgement