Randomized trial of an intensified,multifactorial intervention in patients with advanced-stage diabetic kidney disease: Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan) |
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| Authors: | Kenichi Shikata Masakazu Haneda Toshiharu Ninomiya Daisuke Koya Yoshiki Suzuki Daisuke Suzuki Hitoshi Ishida Hiroaki Akai Yasuhiko Tomino Takashi Uzu Motonobu Nishimura Shiro Maeda Daisuke Ogawa Satoshi Miyamoto Hirofumi Makino the Diabetic Nephropathy Remission Regression Team Trial in Japan (DNETT-Japan) collaborative group |
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| Affiliation: | 1. Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan;2. Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan;3. Department of Epidemiology and Public Health, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan;4. Department of Diabetology & Endocrinology, Kanazawa Medical University, Ishikawa, Japan;5. Health Administration Center, Niigata University, Niigata, Japan;6. Suzuki Diabetes Clinic, Kanagawa, Japan;7. Research Center for Health Care, Nagahama City Hospital, Shiga, Japan;8. Division of Metabolism and Diabetes, Tohoku Medical and Pharmaceutical University, Sendai, Japan;9. Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan;10. Division of Nephrology, Department of Medicine, Nippon Life Hospital, Osaka, Japan;11. Department of Diabetes and Endocrinology, National Hospital Organization Chiba-East National Hospital, Chiba, Japan;12. Department of Advanced Genomic and Laboratory Medicine, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan Division of Clinical Laboratory and Blood Transfusion, University of the Ryukyus Hospital, Okinawa, Japan;13. Okayama Diabetes and Neurology Clinic, Okayama, Japan;14. Okayama University, Okayama, Japan;15. A complete list of steering committee and investigators in the DNETT-Japan is provided in the Appendix S1. |
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| Abstract: | Aims/IntroductionWe evaluated the efficacy of multifactorial intensive treatment (IT) on renal outcomes in patients with type 2 diabetes and advanced‐stage diabetic kidney disease (DKD).Materials and MethodsThe Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT‐Japan) is a multicenter, open‐label, randomized controlled trial with a 5‐year follow‐up period. We randomly assigned 164 patients with advanced‐stage diabetic kidney disease (urinary albumin‐to‐creatinine ratio ≥300 mg/g creatinine, serum creatinine level 1.2–2.5 mg/dL in men and 1.0–2.5 mg/dL in women) to receive either IT or conventional treatment. 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.ResultsThe IT tended to reduce the risk of primary end‐points as compared with conventional treatment, but the difference between treatment groups did not reach the statistically significant level (hazard ratio 0.69, 95% confidence interval 0.43–1.11; P = 0.13). Meanwhile, the decrease in serum low‐density lipoprotein cholesterol level and the use of statin were significantly associated with the decrease in primary outcome (hazard ratio 1.14; 95% confidence interval 1.05–1.23, P < 0.001 and hazard ratio 0.53, 95% confidence interval 0.28–0.998, P < 0.05, respectively). The incidence of adverse events was not different between treatment groups.ConclusionsThe risk of kidney events tended to decrease by IT, although it was not statistically significant. Lipid control using statin was associated with a lower risk of adverse kidney events. Further follow‐up study might show the effect of IT in patients with advanced diabetic kidney disease. |
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| Keywords: | Diabetic kidney disease Diabetic nephropathy Diabetic Nephropathy Remission and Regression Team Trial in Japan |
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