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. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

Welch 1992.

Methods
  • Study design: cross‐over, 2‐arm RCT

  • Time frame: 1983 to 1989

  • Duration of follow‐up: 24 weeks

Participants
  • Setting: single centre

  • Country: USA

  • Inclusion criteria: children with IgAN

  • Number (analysed/randomised): 20/20

  • Mean age: 13 years (SD not reported)

  • Sex (M/F): 15/5

  • Exclusion criteria: SCr ≥140 µmol/L; hypertension (BP consistently 99th percentile for age and gender)

Interventions Two, 3‐month courses of therapy separated by a 3‐month rest period
Treatment group
  • Prednisolone: 2 mg/kg/day for 2 weeks, then every other day for 10 weeks


Control group
  • Placebo: 2 mg/kg/day for 2 weeks, then every other day for 10 weeks


Co‐interventions
  • Not reported

Outcomes
  • Urinary protein excretion

  • SCr

Notes
  • Funding: not reported

  • Trials registration identification number: not applicable

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The first course for each patient was assigned by a random‐numbers table."
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The drugs were dispensed by the Children's Hospital Medical Center pharmacy with a coded label, so that neither patients nor investigators were aware of the identity of the medication."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of outcome assessment not specifically reported. Key outcomes were objective laboratory measures and were unlikely to be affected by any knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants were included in analyses
Selective reporting (reporting bias) High risk Relevant numeric data were not available. Patient‐centred outcomes of relevance were not reported
Other bias Unclear risk Insufficient information to permit judgement