Randomized Trial of an Intensified, Multifactorial Intervention in Patients with Advanced Stage of Diabetic Kidney Disease: Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan).

AIMS/INTRODUCTION We evaluated the efficacy of multifactorial intensive treatment (IT) on renal outcomes in patients with type 2 diabetes and advanced stage of diabetic kidney disease (DKD). MATERIALS AND METHODS Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan) is a multi-centered, open-labeled, randomized controlled trial with a 5-year follow-up. We randomly assigned 164 patients with advanced stage of DKD (urinary albumin-to-creatinine ratio ≥300 mg/g creatinine, serum creatinine level: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female) to receive either IT or conventional treatment (CT). The primary composite outcome was end stage kidney failure, doubling of serum creatinine, or death from any cause, which was assessed in the intention-to treat population. RESULTS The IT tended to reduce the risk of primary endpoints as compared to CT, but the difference between treatment groups did not reach the statistically significant level (hazard ratio (HR), 0.69; 95% confidence interval [CI], 0.43 to 1.11; P=0.13). Meanwhile, the decrease in serum LDL cholesterol level and the use of statin were significantly associated with the decrease in primary outcome (HR, 1.14; 95% CI, 1.05 to 1.23; p<0.001 and HR, 0.53; 95% CI, 0.28 to 0.998; p<0.05, respectively). The incidence of adverse events was not different between treatment groups. CONCLUSIONS The risk of kidney events tended to decrease by IT although it was not statistically significant. Lipid control using statin was associated with lower risk of kidney event. Further follow-up study may show the effect of IT in patients with advanced DKD.