Methods |
Study design: parallel, 2‐arm RCT
Time frame: January 2008 to November 2010
Duration of follow‐up: at least 12 months (12‐60 months)
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Participants |
Setting: single centre
Country: China
Inclusion criteria: adults with biopsy‐proven IgAN; aged 18 to 69 years; urinary protein excretion > 1.0 g/24 hours; eGFR > 30 mL/min/1.73 m2
Number analysed/randomised: treatment group (25/26); control group (23/25)
Mean age ± SD (years): treatment group (36.84 ± 8.06); control group (42.39 ± 13.10)
Sex (M/F): treatment group (12/13); control group (10/13)
Exclusion criteria: IgAN with severe chronic tubulointerstitial damage or crescentics formation of 50% of the glomeruli; IgAN with minimal change syndrome; secondary IgAN, such as that due to lupus nephritis, Henoch‐Schonlein purpura or hepatitis B virus (HBV)‐associated glomerulonephritis; consecutive treatment for more than three months with corticosteroids or immunosuppressive drugs within the previous one year; DM; severe uncontrolled hypertension (a diastolic BP of 120 mmHg); severe liver disease; pregnancy or lactation; and an known allergy or intolerance to the study medication
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Interventions |
Treatment group
Cyclosporin A: 12 month course of cyclosporin A began with a dose of 3 mg/kg/day (before meals, the highest dose was 200 mg/d). The dose was reduced by 25% when the SCr level increased by more than 25% of the baseline value. Twelve weeks later, the dose was gradually reduced by 50 mg every month then maintained at a maintenance dose of 25 mg/d.
Methylprednisolone: at the same time, the patients were given a medium dose of methylprednisolone of 0.4 mg/kg/d (the highest dose was 36 mg/d) orally for 8 weeks, after which the dose was tapered by 4 to 8 mg every 2 weeks to a maintenance dose of 4 mg/d or 4 mg every other day
Control group
Co‐interventions (both groups)
Losartan: 50 mg/day
Dipyridamole: 50 mg/day
|
Outcomes |
Complete remission
Decrease in eGFR
Relapse in proteinuria
Severe adverse effects
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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 |
High risk |
Blinding of outcome assessment not specifically reported. Key outcomes were objective laboratory measures and were unlikely to be affected by any knowledge of treatment allocation. However, reporting of adverse events may have been influenced by knowledge of treatment allocation |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Three patients were lost to follow‐up (one from the steroid group, two from the combination group), and two patients in the combination group discontinued cyclosporin A after three months of treatment due to severe pulmonary infections. After six months of treatment, one patient in the steroid group without a response to treatment was converted to cyclosporin A |
Selective reporting (reporting bias) |
High risk |
Key outcomes expected for this type of study (death (any cause), infection, ESKD) were not reported |
Other bias |
Low risk |
The study appeared to be free of other sources of bias |