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. 2021 Nov 15;2021(11):CD004293. doi: 10.1002/14651858.CD004293.pub4

Koshikawa 1993.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: April 1989 to June 1992

  • Duration of follow‐up: 24 weeks

Participants
  • Setting: not reported

  • Country: Japan

  • Inclusion criteria: biopsy‐proven IMN with steroid‐resistant nephrotic syndrome

  • Baseline characteristics

    • Pathology stage: not reported

    • GFR: ≥ 50 mL/min

    • Baseline declining kidney function: not reported

    • Previous immunosuppressive status: receiving a daily maintenance dose of 20 mg prednisolone‐equivalent a day (including zero dosage) before entry was allowed. Other immunosuppressant medication should be stopped at the start of the study

  • Number: treatment group (48); control group (41)

  • Age: > 15 years

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Mizoribine: 50 mg 3 times/day after meals for 24 weeks


Control group
  • Placebo


Co‐interventions
  • Use of ACEi or ARB during follow‐up: not reported

Outcomes
  • 50% or 100% SCr increase

  • Partial or complete remission

  • Side effects leading to patient withdrawal or hospitalisation

Notes
  • Funding information: not reported

  • Published in Japanese

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk No sufficient detail about concealment of the random allocation sequence before or during enrolment of participants
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind; no information on blinding of outcome‐assessors provided
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk Only 2/48 patients in the treatment group did not complete 24‐week follow‐up
Selective reporting (reporting bias) High risk The primary outcome such as death and ESKD were not reported
Other bias High risk The data were abstracted from a RCT aiming to investigate the effect of mizoribine on steroid‐resistant primary nephrotic syndrome. This study included all different pathologic variants of nephrotic syndrome. The randomisation was not stratified according to the pathologic diagnosis