Study characteristics |
Methods |
Study design: parallel, open‐label RCT
Study duration: January 2008 to January 2013
Duration of follow‐up: 6 to 48 months; mean duration was 13.5 ± 6.2 months
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Participants |
Setting: single centre
Country: China
Age: 65‐81 years
Sex: 15 men, 12 women
Inclusion criteria: IMN confirmed by biopsy examined using light microscopy, immunofluorescence, and electron microscopy, and the condition of the patients was pathologically diagnosed as IMN stage I and II; 24‐hour protein levels > 4 g; > 65 years
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Baseline characteristics
Mean proteinuria ± SD (g/24 hours): treatment group (7.5 ± 3.8); control group (7.2 ± 3.4)
Mean eGFR ± SD (mL/min/1.73 m²): treatment group (70.9 ± 11.9); control group (69.6 ± 10.3)
Mean triglyceride ± SD (mmol/L): not reported
SCr (µmol/L): treatment group (91.6 ± 20.9); control group (98.8 ± 15.1)
Mean serum cholesterol ± SD (mmol/L): not reported
Disease‐course (time since diagnosis) at immunosuppressive treatment initiation: not reported
Pathological classification: stage I or stage 2
Co‐morbidities: not reported
Co‐medications: all patients received lipid‐lowering drugs and anti‐platelet adhesion drugs. BP was controlled to target < 140/90 mm Hg
Number: treatment group (13); control group (14)
Mean age (years): treatment group (74.8): control group (75.1)
Sex (M/F) 15/12: treatment group (10/3); control group (10/4)
Exclusion criteria: secondary membranous nephropathy induced by secondary factors such as autoimmune diseases, cancer, infections and drugs, or atypical membranous nephropathy; HIV infection; diagnosed with malignant tumour infection; active hepatitis B or C or with positive replication indexes
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Interventions |
Treatment group
CSA (oral) initial dose was 2 mg/kg/day and the treatment duration was not less than 6 months
Methylprednisolone (oral): initial dose was 0.4 mg/kg/day which gradually decreased after 8 to 12 weeks administration; the total duration of treatment was 6 to 12 months
Control group
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Outcomes |
Clinical remission rate: complete + partial remission / total number of patients x 100%
Complete remission: defined as urinary protein level ≤ 0.3 g/day, serum albumin level > 35 g/L, stable kidney function (increase in the SCr < 15% of the baseline value)
Partial remission: defined as the decrease in urinary protein level by more than 50% of the baseline value, urinary protein level ≤ 3.5 g/day, stable kidney function
No remission: defined as the decrease in the urinary protein level less than 50% of the baseline value, or the urinary protein level was > 3.5 g/day or the SCr > 50% of the baseline value
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Safety
Adverse reactions observed during the treatment were infection, osteonecrosis, steroid glycosuria, and hepatonephritic toxicity, and patients discontinued treatment
Complications were steroid diabetes
Hypertension (uncontrollable)
Infection
SCr increase > 50%
Recurrence rate after drug withdrawal
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Notes |
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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 |
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 |
Reasonable and comprehensive outcome reporting. Unable to determine if more were randomised than reported |
Selective reporting (reporting bias) |
Low risk |
Reports on remissions, most appropriate outcome. All outcomes were reported |
Other bias |
Low risk |
No evidence for other bias. no evidence for conflict of interest, however, no trial protocol published |