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

Pozzi 1999.

Methods
  • Study design: parallel, 2‐arm RCT

  • Duration of study: July 1987 to September 1995

  • Duration of follow‐up: 6 years

Participants
  • Setting: multicentre (7)

  • Country: Italy

  • Inclusion criteria: aged 15 to 69 years; biopsy‐proven IgAN; proteinuria 1.0 to 3.5 g/day for at least 3 months, and SCr ≤ 133 mol/L

  • Number (analysed/randomised): treatment group (not reported/43); control group (not reported/43)

  • Mean age, range (years): treatment group (38, 26 to 45); control group (40, 29 to 51)

  • Sex (M/F): not reported

  • Exclusion criteria: treatment with steroids or cytotoxic drugs during the previous 3 years; pregnancy; HSP nephritis; systemic lupus nephritis; diabetes; neoplasia; active peptic‐ulcer disease, viral hepatitis; other infections

Interventions Treatment group
  • Methylprednisolone: 1g IV for 3 days, repeated at 2 and 4 months

  • Prednisone 0.5 mg/kg/day on alternating days for 6 months


Control group
  • No treatment


Co‐interventions
  • Both groups of patients were administered diuretics, antihypertensive drugs and antiplatelet agents as needed. ACEi were allowed for the treatment of hypertension

Outcomes
  • ESKD

  • SCr

  • CrCl

  • Urinary protein excretion

  • Adverse events

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 Centralised table of random numbers
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes High 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. However, reporting of adverse events may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes High risk All patients in the steroid group completed the 6 months of therapy; high dropout in both groups after this period
Selective reporting (reporting bias) Low risk Data for outcomes such as death (any cause), and infection were not reported. All other outcomes that would be expected for this type of study were reported
Other bias High risk Four patients in the control group received steroids as rescue therapy