Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study in Japan.

AIMS/INTRODUCTION: The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial has shown the effects of canagliflozin on preventing clinically important kidney outcomes in patients with type 2 diabetes mellitus and chronic kidney disease; however, not many Japanese patients were included in the trial. The present study evaluated the efficacy and safety of canagliflozin in Japanese chronic kidney disease patients with type 2 diabetes mellitus.

MATERIALS AND METHODS

In this multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study, chronic kidney disease patients with type 2 diabetes mellitus were randomly assigned to receive either 100 mg canagliflozin or a matching placebo once daily for 104 weeks. The primary efficacy end-point was the incidence of a 30% decline in estimated glomerular filtration rate.

RESULTS

Overall, 308 patients were randomized to the canagliflozin (n = 154) and placebo (n = 154) groups. The incidence of a 30% decline in estimated glomerular filtration rate at week 104 was 18.2% and 29.5%, respectively, and the point estimate of the intergroup difference (placebo - canagliflozin) was 11.3% (95% confidence interval 1.2-21.5, P = 0.029), which was significant. The overall incidence of adverse events was similar in the two groups.

CONCLUSIONS

This study suggests that canagliflozin safely reduces the risk of end-stage renal disease in Japanese chronic kidney disease patients with type 2 diabetes mellitus.