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

Cheung 2018.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame: not reported

  • Duration of follow‐up: intervention administered for 52 weeks; subjects will be followed for a further 12 months

Participants
  • Setting: multicentre

  • Country: The UK

  • Inclusion criteria: biopsy‐proven IgAN with persistent proteinuria (24 h urine protein excretion > 0.5 g) despite best supportive measures are at increased risk of progression to ESKD

  • Number (analysed/randomised): not reported/21

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: Subjects with severely reduced kidney function

Interventions Treatment group
  • Belimumab (Benlysta ‐ IgG1 monoclonal antibody) given fortnightly then monthly by IV infusion at a dose of 10 mg/kg


Control group
  • Placebo


Co‐interventions
  • ACEi or ARB

Outcomes
  • Percent change from baseline in UPCR at week 52

  • Change from baseline in eGFR at week 52

  • Levels of poorly glycosylates IgA1, IgA1 immune complexes, pharmacodynamic biomarker

  • QoL

Notes
  • Conference abstract

  • Trials registration identification number: not reported

  • Funding: 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 Low risk Double‐blind 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. Interpretation of subjective outcomes may have been influenced by knowledge of treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk There was no pre‐specified protocol identified for this study. The study did not report extractable data for the key outcomes that would be expected for a study of this type (e.g., death (any cause), infection, malignancy, ESKD, doubling of SCr, complete remission, SCr)
Other bias Unclear risk Insufficient information to permit judgement