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

Fu 2012a.

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

  • Study duration: not reported

  • Duration of follow‐up: 36 months

Participants
  • Setting: not reported

  • Country: China

  • Inclusion criteria: biopsy‐proven IMN and nephritic syndrome; CD I & II; never had prednisolone or immunosuppression before

  • Baseline characteristics

    • Mean proteinuria ± SD (g/24 hours): treatment group (9.57 ± 8.94); control group (9.42 ± 2.86)

    • Mean serum albumin ± SD (g/L): treatment group (23.4 ± 4.3); control group (23.5 ± 6.8)

    • Mean eGFR ± SD (mL/min/1.73 m²): treatment group (95.7 ± 21.6); control group (96.1 ± 17.8)

    • Mean SCr ± SD (µmol/L): treatment group (68.8 ± 20.2); control group (66.3 ± 15.7)

    • Mean serum cholesterol ± SD (mmol/L): treatment group (8.47 ± 3.17); control group (8.38 ± 2.56)

    • Disease‐course (time since diagnosis) at immunosuppressive treatment initiation: not reported

    • Pathological classification: not reported

    • Co‐morbidities: nephritic syndrome

  • Number: treatment group (13); control group (13)

  • Mean age ± SD (years): treatment group (43.1 ± 11.9); control group (42.7 ± 14.5)

  • Sex (M/F): treatment group (9/4); control group (8/5)

  • Exclusion criteria: secondary membranous nephropathy

Interventions Treatment group
  • MMF + prednisone for 36 months

    • MMF: 2 g/day split into 2 doses. After 6 months reduced to 1.5g/day; after 18 months 1g/day; after 30 months reduced to 0.5 g/day until gradually stopped

    • Prednisone: initial dose 1 mg/kg/day in the morning, then gradually decreased for 6 weeks afterwards tapering 5 mg/weeks until 10 to 20 mg/week as maintenance treatment


Control group
  • CPA + prednisone for 36 months

    • CPA (IV): 1 g every month for 6 months, then every 3 months for 46 times

    • Prednisone: initial dose 1 mg/kg/day in the morning, then gradually decreased


Both groups
  • If worsening of IMN, then the maintenance of dose for 3 months before beginning the reduction. Initial dose of prednisone was 1 mg/kg/day in the morning and then gradually decreased in both groups

  • Co‐medications: not reported

Outcomes
  • 24‐hour urine protein excretion

  • Serum albumin

  • SCr

  • eGFR

  • WCC

  • Remission

  • Leucopenia

  • Abnormal liver enzymes


Follow‐up at 3, 12, 24 and 36 months
Notes
  • Funding information/COI: authors reported no conflict of interest.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement. Groups are very similar in baseline characteristics, unlikely by chance. indicating some form of matching
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 evidence of attrition bias. all patients completed course of the study
Selective reporting (reporting bias) Low risk No evidence of selective reporting. comprehensive reporting on all outcomes
Other bias Low risk No evidence of other bias. authors declare no conflict of interest