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

Chan 2007.

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

  • Study duration: before 2007

  • Duration of follow‐up: 15 to 24 months

Participants
  • Setting: not reported

  • Country: China

  • Inclusion criteria: biopsy‐proven IMN with proteinuria of ≥ 3 g/day

  • Baseline characteristics

    • Pathology stage: not reported

    • Mean proteinuria ± SD (g/24 hours): 5.7 ± 2.7

    • Hypertension: 14/20

    • Mean serum albumin ± SD (g/L): 26.5 ± 7.5

    • Mean SCr ± SD (μmol/L): treatment group 1 (103.3 ± 48.7); treatment group 2 (85.7 ± 31.8)

    • Mean GFR ± SD (mL/min): treatment group 1 (87.1 ± 38.5); treatment group 2 (101.8 ± 40.6)

    • Baseline declining kidney function: initial Cr was < 300 μmol/L in all included patients 3/20 patients (2 in the MMF group and 2 in the control group) had abnormal SCr at baseline

    • Use of ACEi or ARB during follow‐up: in view of their confounding effects on proteinuria and kidney function, ACEi and ARB were not started during the study, and if a patient was already on either medication at the start of the study, the dose was kept unchanged. Only 1 patient was receiving ACEi prior to the study, and the dose was kept unchanged

    • Previous immunosuppressive status: those who had received cytotoxic or CSA treatment within the previous 12 months, or who had received prednisolone at ≥ 20 mg/day for 4 weeks or more within the past 6 months, were excluded

  • Number: treatment group 1 (11); treatment group 2 (9)

  • Mean age ± SD (years): 49.5 ± 13.5

  • Sex (M/F): 13/7

  • Exclusion criteria: clinical evidence or suspicion of an underlying aetiology (such as infection, malignancy, systemic autoimmune disease); those who had received cytotoxic or cyclosporine treatment within the previous 12 months, or who had received prednisolone at 320 mg/day for 4 weeks or more within the past 6 months

Interventions Treatment group 1
  • MMF: 1 g twice/day was given for 6 months

  • Prednisolone (oral): started at 0.8 mg/kg/day, then tapered by 5 mg/day every fortnight until reaching 10 mg/day at around 4 months, then tapered by 2.5 mg/day every fortnight, till total withdrawal at around 6 months from baseline. The cumulative dose of prednisolone was 3.80 ± 0.28 g


Treatment group 2
  • Modified Ponticelli regimen

    • Methylprednisolone (IV): 1 g/day for 3 days, followed by oral prednisolone 0.4 mg/kg/day for 3 weeks, then 0.2 mg/kg/day till the end of the month, alternating with chlorambucil 0.2 mg/kg/day for 1 month, for a total duration of 6 months. The cumulative dose of prednisolone was 9.93 ± 0.25 g

Outcomes
  • Death

  • ESKD

  • Final GFR

  • Partial or complete remission

  • Final proteinuria

  • Side effects leading to patient withdrawal or hospitalisation

Notes
  • Funding information: the study received partial funding support from the Wai Hung Charity Foundation and Roche Pharmaceuticals (Hong Kong). The donors had no role in the study design and execution, data analysis and interpretation, or writing of the report

  • Sample size calculation: 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 Patients who satisfied the selection criteria were randomised by drawing envelope into either one of two treatment groups
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 All patients completed the study and there were no losses to follow‐up
Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were pre‐specified
Other bias Unclear risk Insufficient information to permit judgement