51. Rationale, design and baseline characteristics of the effect of canagliflozin in patients with type 2 diabetes and microalbuminuria in the Japanese population: The CANPIONE study
- Author
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Satoshi, Miyamoto, Hiddo J L, Heerspink, Dick, de Zeeuw, Masao, Toyoda, Daisuke, Suzuki, Takashi, Hatanaka, Tohru, Nakamura, Shinji, Kamei, Satoshi, Murao, Kazuyuki, Hida, Shinichiro, Ando, Hiroaki, Akai, Yasushi, Takahashi, Daisuke, Koya, Munehiro, Kitada, Hisashi, Sugano, Tomokazu, Nunoue, Akihiko, Nakamura, Motofumi, Sasaki, Tatsuaki, Nakatou, Kei, Fujimoto, Daiji, Kawanami, Takashi, Wada, Nobuyuki, Miyatake, Michihiro, Yoshida, Kenichi, Shikata, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Groningen Kidney Center (GKC) more...
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CHRONIC KIDNEY-DISEASE ,Male ,eGFR slope ,OUTCOMES ,NEPHROPATHY ,Endocrinology, Diabetes and Metabolism ,INHIBITION ,SGLT2 inhibitor ,Middle Aged ,diabetic kidney disease ,Endocrinology ,Diabetes Mellitus, Type 2 ,Japan ,CANPIONE study ,urinary albumin-to-creatinine ratio ,SAMPLE-SIZE ,Internal Medicine ,CKD ,Albuminuria ,Humans ,Female ,Canagliflozin ,Sodium-Glucose Transporter 2 Inhibitors ,CLINICAL-TRIALS ,Glomerular Filtration Rate - Abstract
Aim To evaluate the effect of canagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, on albuminuria and the decline of estimated glomerular filtration rate (eGFR) in participants with type 2 diabetes and microalbuminuria. Methods The CANPIONE study is a multicentre, randomized, parallel-group and open-labelled study consisting of a unique 24-week preintervention period, during which the rate of eGFR decline before intervention is estimated, followed by a 52-week intervention and a 4-week washout period. Participants with a geometric mean urinary albumin-to-creatinine ratio (UACR) of 50 and higher and less than 300 mg/g in two consecutive first-morning voids at two different time points, and an eGFR of 45 ml/min/1.73m2 or higher, are randomly assigned to receive canagliflozin 100 mg daily or to continue guideline-recommended treatment, except for SGLT2 inhibitors. The first primary outcome is the change in UACR, and the second primary outcome is the change in eGFR slope. Results A total of 258 participants were screened and 98 were randomized at 21 sites in Japan from August 2018 to May 2021. The mean baseline age was 61.4 years and 25.8% were female. The mean HbA1c was 7.9%, mean eGFR was 74.1 ml/min/1.73m2 and median UACR was 104.2 mg/g. Conclusions The CANPIONE study will determine whether the SGLT2 inhibitor canagliflozin can reduce albuminuria and slow eGFR decline in participants with type 2 diabetes and microalbuminuria. more...
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- 2022