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

APN 1981.

Study characteristics
Methods Study design
  • Parallel RCT

  • Time frame: not reported

  • Duration of follow‐up: 12 months

  • Country: Germany and Switzerland

  • Setting: multicentre (11 sites)

Participants Study characteristics
  • Inclusion criteria: children with FRNS

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (23/30); intervention group 2 (25/34)

  • Mean age ± SD (months): intervention group 1 (88.5 ± 33.0); intervention group 2 (101.3 ± 35.1)

  • Sex (M/F): intervention group 1 (15/8); intervention group 2 (18/7)

Interventions Intervention group 1 (alternate)
  • Prednisone: 60 mg/m2/day till protein free for 3+ days; then 35 mg/m2 on alternate days

  • Total duration: 6 months


Intervention group 2
  • Prednisone: 60 mg/m2/day till protein free for 3+ days; then 40 mg/m2 given on 3/7 consecutive days

  • Total duration: 6 months

Outcomes Outcomes relevant to this review
  • Number relapsing during 6 months of therapy and in subsequent 6 months

  • Mean relapse rate during treatment and in subsequent 6 months

Notes Additional information
  • Definitions

    • FRNS: 2+ relapses within 6 months of first response or 4 relapses in any 1 year (ISKDC definition)

    • Relapse: urine protein > 40 mg/m2/h for 3 consecutive days (ISKDC)

    • Remission: urinary protein < 4 mg/m2/h for 3 consecutive days (ISKDC)

  • Funding source: supported by grants from the VW Foundation

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about sequence generation to permit judgement
Allocation concealment (selection bias) Low risk Sealed envelopes provided to each centre
QUOTE: "One opened when patient qualified to enter the study"
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding not mentioned and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding of outcome assessment not mentioned and outcome measurement likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes High risk 16/64 withdrawn: steroid toxicity (8); incorrect treatment or uncooperative parents (6); late non‐response (1); one patient unaccounted for in the text
Selective reporting (reporting bias) Low risk Recorded the review's pre‐specified outcomes (number with relapse, frequency of relapses, adverse events)
Other bias Low risk Supported by grants from the VW Foundation