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. 2021 Nov 15;2021(11):CD004293. doi: 10.1002/14651858.CD004293.pub4

Jurubita 2012.

Study characteristics
Methods
  • Study design: parallel, open‐label RCT

  • Study duration: before 2012

  • Duration of follow‐up: 12 months

Participants
  • Setting: single centre

  • country: Romania

  • Inclusion criteria: biopsy‐proven IMN with persistent heavy proteinuria (> 8 g/day, minimum 6 months)

  • Baseline characteristics

    • Pathology stage: not reported

    • Mean proteinuria, range (g/24 hours): treatment group 1 (10.4, 8.4 to 14.9); treatment group 2 (10.26, 8 to 14.1)

    • GFR (mL/min/1.73 m²): > 60

    • Baseline declining kidney function: not reported

    • Previous immunosuppressive status: not reported

  • Number: treatment group 1 (9); treatment group 2 (9)

  • Mean age ± SD (years): not reported

  • Sex: not reported

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • MMF: 1 g/day

  • CSA: 2 mg/kg/day, but not exceeding 150 mg/day

  • Prednisolone: 0.15 mg/kg/day

  • Duration: 12 months


Treatment group 2
  • CSA: 5 mg/kg/day, but not exceeding 150 mg/day

  • Prednisolone: 0.15 mg/kg/day


Co‐interventions
  • Use of ACEi or ARB during follow‐up: not reported

Outcomes
  • Partial or complete remission

Notes
  • Funding information: not reported

  • Only abstract was available and unpublished data were not used

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 Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk No patient was lost to follow‐up, and an intention‐to‐treat analysis was used
Selective reporting (reporting bias) High risk Only remission data were provided in the abstract
Other bias Unclear risk Only abstract was available and unpublished data were not used