02682nas a2200277   4500000000100000008004100001100002100042700001700063700001700080700001600097700001500113700001800128700001900146700001900165700002100184700001900205700001800224700003900242700001900281700001500300245016200315300001200477490000700489520189400496022001402390       2017                            d1 aMahaffey Kenneth1 aFulcher Greg1 aErondu Ngozi1 aDesai Mehul1 aShaw Wayne1 ade Zeeuw Dick1 aMatthews David1 aMeininger Gary1 aVercruysse Frank1 aYee Jacqueline1 aDeng Hsiaowei1 aCANVAS-R Trial Collaborative Group1 aPerkovic Vlado1 aNeal Bruce00aRationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): A randomized, placebo-controlled trial.  a387-3930 v193 a<p>
<b>AIMS: </b>The primary aim of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) is to determine whether the favourable effects of inhibition of the sodium glucose co-transporter 2 (SGLT2) on blood glucose, blood pressure and body weight are accompanied by protection against adverse renal outcomes.
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<b>MATERIALS AND METHODS: </b>CANVAS-R is a prospective, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes with a history or high risk of cardiovascular events. Patients were randomly assigned to once-daily placebo or canagliflozin 100 mg (with optional uptitration to 300 mg) for a planned average of 2.5 years of follow-up. The primary outcome is kidney disease progression, defined by class change in albuminuria. The two secondary outcomes are the composite of hospitalized heart failure or cardiovascular death, and cardiovascular death alone. Effects on end-stage renal disease and a range of other outcomes will also be explored.
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<b>RESULTS: </b>A total of 5812 participants were recruited at 422 sites in 24 countries between January 2014 and May 2015. The mean baseline age was 64 years, mean duration of diabetes was 14 years, mean glycated haemoglobin level was 8.3% and mean body mass index was 32 kg/m(2) . Of these participants, 37% were women, 71% had a history of cardiovascular disease, 22.3% had microalbuminuria and 8.7% had macroalbuminuria. The mean baseline estimated glomerular filtration rate was 76 mL/min/1.73 m(2) . The study will have at least 90% power ( P = .05) to detect a 22% or greater reduction in the risk of progression of albuminuria.
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<b>CONCLUSIONS: </b>The trial should define the potential renoprotective effect of canagliflozin and will provide additional important new data about its effects on vascular outcomes, death and kidney failure.
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