Study characteristics |
Methods |
Study design: parallel, open‐label RCT
Study duration: before 2007
Duration of follow‐up: 15 to 24 months
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Participants |
Setting: not reported
Country: China
Inclusion criteria: biopsy‐proven IMN with proteinuria of ≥ 3 g/day
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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
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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
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Outcomes |
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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
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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 |