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

Segarra 2006.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: 24 months

Participants
  • Setting: multicentre (number of sites not reported)

  • Country: Spain

  • Inclusion criteria: IgAN; persistent proteinuria >2.5 g/day; GFR > 30 mL/min; BP < 130/80 mmHg

  • Number (analysed/randomised): treatment group (19/not reported); steroid group (17/not reported)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: not reported

Interventions Treatment group
  • Immunoglobulin: 0.4 g/kg/day administered during 4 consecutive days every month

  • Steroid: 1 mg/kg/d for 4 weeks and then reduced at a rate of 5 mg/day every week until suppression


Control group
  • Steroid: 1 mg/kg/d for 4 weeks and then reduced at a rate of 5 mg/day every week until suppression


Co‐intervention: not reported
Outcomes
  • Remission of proteinuria (< 1 g/day)

  • SCr

  • GFR

  • 24 hour proteinuria

  • Serum IgA

  • Complement

  • Secretory IgA

  • IL‐6. IL‐8, MCP‐1, TGF beta

  • Adverse events

Notes
  • Abstract‐only publication

  • Funding: not reported

  • Trials registration identification number: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
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. Reporting of adverse events may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes High risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk Key outcomes expected for this type of study were not reported
Other bias High risk Insufficient information to permit judgement