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

BRIGHT‐SC 2016.

Methods
  • Study design: parallel, 2‐arm RCT

  • Time frame

    • Study start date: June 2013

    • Study primary completion date: March 2017

    • Actual study completion date: 30 June 2017

  • Duration of follow‐up: 6 months

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

  • Country: Czech Republic, Germany, Hong Kong, Republic of Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, UK

  • Inclusion criteria: biopsy‐proven IgAN; UPCR 1 to 6 g/g; eGFR > 30 mL/min/1.73 m2, on renin‐angiotensin blockade

  • Number (analysed/randomised): 47/57

  • Mean age ± SD (years): not reported

  • Sex (M/F): 45% men

  • Exclusion criteria: clinical or histologic evidence of non‐IgA‐related GN; IgA nephropathy > 50% glomerulosclerosis or cortical scarring; meets eGFR criteria; history of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months; malignancy within past 5 years; known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C; liver disease; neutropenia; active infection requiring hospitalisation or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections; history of active tuberculosis or a history of tuberculosis infection; pregnant or nursing

Interventions Treatment group
  • Blisibimod: 100 mg 3 times/week for 8 weeks, then 200 mg/week


Control group
  • Placebo


Co‐interventions
  • Not reported

Outcomes
  • ESKD

  • eGFR

  • UPCR

  • Serum immunoglobulins IgA, IgG and IgM

  • Plasma cells and B‐cell subsets

  • Complement C3 and C4

  • Requiring addition of corticosteroid therapy

Notes
  • Conference abstract

  • Responsible party: Anthera Pharmaceuticals. Results submitted to trial registry; currently in quality control

  • Funding: Anthera Pharmaceuticals

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 Low risk Outcome assessment was not reported. However, the study outcomes of interest were objectively measured, therefore this was adjudicated as low risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes High risk 10/57 participants did not complete 6 months of study follow‐up and were not included in analysis. It was not clear whether there was differential loss in the treatment groups and the reasons for dropout were not provided
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), GFR loss, infection, malignancy)
Other bias Unclear risk Insufficient information to permit judgement. Methods of randomisation, baseline characteristics were not reported to assess quality of randomisation