[7-9] However, for IgA nephropathy patients with significant risk for rapid disease progression,[12, 13] it is still unclear whether the addition of anti-oxidant therapy increases the therapeutic efficacy. In the present study, to examine of the clinical benefits and safety of

probucol (an anti-oxidant and anti-hyperlipidemic agent) in combination with valsartan (an ARB) in patients with IgA nephropathy, we conducted a multi-centre, open labelled, randomized controlled study. This multi-centre, see more randomized, open-label, controlled and parallel clinical trial enrolled patients with biopsy-proven IgA nephropathy from January 2007 to January 2010. The inclusion criteria were: age of 18–75 years; 24-h urinary protein of 1.0–3.0 g; serum creatinine no more than 265.2 μmol/L; no treatment with an angiotensin converting enzyme inhibitor (ACEI), ARB, anti-oxidant, lipid-lowering drug in click here the previous 6 weeks, and no treatment with steroid or cytotoxic drug within the previous 6 months. Patients with any of the following were excluded: secondary IgA nephropathy (Henoch-schonlein purpura nephritis, hepatitis

B virus associated glomerulonephritis, cirrhosis, lupus nephritis, connective tissue diseases), malignant hypertension, acute kidney injury, crescentic glomerulonephritis, diabetes, renal artery stenosis, obstructive nephropathy, pregnancy, tumour, active gastrointestinal ulcer, coronary heart disease, cardiomyopathy, serious arrhythmia, cerebrovascular disease, and active infection (including tuberculosis). Patients who did not comply with the Suplatast tosilate treatment were also excluded. A computer-generated list that was maintained by a third party not involved in the conduct of the study was used for randomization. Investigators were unaware of the randomization schedule when recruiting patients, and both investigators and patients were not blinded during the follow-up period. Two pathologists who were blinded to this study independently made all of the pathological examinations. At the end of study, the pathologists used the Oxford classification system

of IgA nephropathy to evaluate renal tissue sections. The study protocol was approved by the institutional review boards at each site, and all patients gave written, informed consent. All study procedures were performed in accordance with the principles of the Declaration of Helsinki. The flow chart of the study was shown in Figure 1. All 75 eligible patients were screened before formal enrolment. For screening, patients were treated with 80 mg/day valsartan for 4 consecutive weeks, during which blood pressure, serum potassium, serum creatinine, and cough were monitored. After 4 weeks, patients who had serum potassium less than 5.5 mmol/L, an increase in serum creatinine less than 30%, and without intolerable side-effects related to valsartan therapy were given 160 mg/day valsartan for 4 weeks.