Methods |
Study design: parallel, 3‐arm RCT
Time frame: June 2009 to June 2012
Duration of follow‐up: 12 months
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Participants |
Setting: multicentre (8 sites)
Country: China
Inclusion criteria: pathologically diagnosed primary IgAN by renal biopsy; mean urinary protein excretion on 2 measurements within 1 week of 0.5 to 3.5 g/24 hours; mean SCr level on 2 measurements within 1 week of 353.6 mol/L; age of 14 to 70 years regardless of sex; and lack of use of steroids, immunosuppressants, ACEi and ARB drug within the 3‐month period preceding the study
Number (analysed/randomised): treatment group 1 (25/30); treatment group 2 (29/35); control group (30/34)
Mean age ± SD (years): treatment group 1 (33.67 ± 11.62); treatment group 2 (33.63 ± 11.71); control group (33.68 ± 10.29)
Sex (M/F): treatment group 1 (14/16); treatment group 2 (14/21); control group (14/20)
Exclusion criteria: sensitivity to mizoribine or losartan; leukocyte count 3000/mm3; pregnant or desiring to be pregnant; and secondary IgAN (SLE, hypersensitive purpura, type B hepatitis, cirrhosis, etc)
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Interventions |
Treatment group 1
Treatment group 2
Control group
Co‐interventions
Calcium antagonists, beta‐receptor blockers or alfa‐receptor blockers could be used for patients with hypertension in the losartan group and the combination group whose BP was higher than 130/80 mmHg despite oral administration of losartan 100 mg; in addition, the same drugs could be used for patients with hypertension in the mizoribine group. The target BP was 130/80 mmHg. The use of steroids, immunosuppressants other than mizoribine, ACEi and ARB other than losartan was excluded
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Outcomes |
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Notes |
The protocol was registered with the Cochrane Renal Prospective Trial Registry in 2006 and also with the Australian and New Zealand Clinical Trial Registration Centre in 2009
This study was supported by the Key Program of the National Natural Science Foundation of China (Grant No.30630033), National Key Technologies R&D Program of China (Grant No. 2007BAI04B10) and Science and Technology Project of Beijing, China (Grant No. D09050704310904)
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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 |
Low 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 |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
6/35 participants in mizoribine group did not complete study. 4/34 participants in combination group did not complete study. 5/30 participants in the losartan group did not complete study |
Selective reporting (reporting bias) |
High risk |
Key outcomes expected for this type of study (death (any cause), ESKD) were not reported |
Other bias |
Low risk |
The study appeared to be free of other source of bias |