| Methods |
Study design: parallel, 4‐arm RCT Time frame: June 2009 to June 2012 Duration of follow‐up: 6 months |
| Participants |
Setting: multicentre (13 sites) Country: China Inclusion criteria: 18 to 55 years; biopsy confirmed (within the past year) IgAN of Lee’s grade II–IV, proteinuria of 0.5 to 3.5 g/day, SCr < 265 μmol/L, and BP between 90/60 and 130/80 mmHg with or without antihypertensive treatments Number (analysed/randomised): treatment group 1 (100/100); treatment group 2 (100/100); treatment group 3 (100/100); treatment group 4 (99/99) Mean age ± SD (years): treatment group 1 (39.01 ± 9.78); treatment group 2 (36.52 ± 9.59); treatment group 3 (38.12 ± 10.62); treatment group 4 (37.06 ± 10.46) Sex (M/F): treatment group 1 (54/46); treatment group 2 (61/39); treatment group 3 (54/46); treatment group 4 (62/37) Exclusion criteria: IgAN secondary to other diseases; previous adverse reaction to telmisartan, clopidogrel, or leflunomide; DM; pregnancy or unreliable contraception; and use of corticosteroids or other immunosuppressive agents (including leflunomide) in the preceding 3 months |
| Interventions |
Treatment group 1
Telmisartan: 80 mg/day Clopidogrel placebo Leflunomide placebo
Treatment group 2
Telmisartan: 80 mg/day Clopidogrel: 50 mg/day Leflunomide placebo
Treatment group 3
Telmisartan: 80 mg/day Clopidogrel placebo Leflunomide: 20 mg/day
Treatment group 4
Telmisartan: 80 mg/day Clopidogrel: 50 mg/day Leflunomide: 20 mg/day
Co‐interventions
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| Outcomes |
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| Notes |
This work is supported by the grants from National Key Technology Research and Development Program (No. 2011BAI10B00); from National High Technology Research and Development Program of China (863 Program No. 2012AA02A512); two grants from National Clinical Research Center for Kidney Disease (No. 2013BAI09B05 and No. 2015BAI12B06), and from the Science and Technology Project of Beijing, China (No. D09050704310904, No. D131100004713003)
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation list was produced by a staff member at the Peking University Clinical Research Institute (Beijing, China) who was not otherwise involved in the study |
| Allocation concealment (selection bias) |
Unclear risk |
Detailed blind coding was recorded and covertly preserved in the coordinating centre. Each study centre was randomly stratified according to the enrolment order |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind 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 |
In total, 25/400 patients were lost to follow‐up. However the proportion was low, the proportion of loss to follow‐up was different for each treatment group |
| Selective reporting (reporting bias) |
Low risk |
All relevant outcomes were reported |
| Other bias |
Low risk |
The study appeared to be free of other sources of bias |
