Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan): Rationale and study design

Shikata, Kenichi; Haneda, Masakazu; Koya, Daisuke; Suzuki, Yoshiki; Tomino, Yasuhiko; Yamada, Kenichi; Maeda, Shiro; Kawakami, Norito; Uzu, Takashi; Nishimura, Motonobu; Sato, Chikage; Ogawa, Daisuke; Makino, Hirofumi; DNETT-Japan Study Group,

doi:10.1016/j.diabres.2009.09.025

« Previous Next »Diabetes Research and Clinical Practice
Volume 87, Issue 2 , Pages 228-232, February 2010

Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan): Rationale and study design

Kenichi Shikata
- Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
Masakazu Haneda
- Department of Medicine, Division of Metabolism and Biosystemic Science, Asahikawa Medical College, Asahikawa, Japan
Daisuke Koya
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Kanazawa Medical University, Ishikawa, Japan
Yoshiki Suzuki
- Health Administration Center, Niigata University, Niigata, Japan
Yasuhiko Tomino
- Division of Nephrology, Department of Internal Medicine, Juntendo University School of Medicine, Tokyo, Japan
Kenichi Yamada
- Metabolic Diseases Clinic, Chiba, Japan
Shiro Maeda
- Laboratory for Endocrinology and Metabolism, RIKEN Center for Genomic Medicine, Yokohama, Japan
Norito Kawakami
- Department of Mental Health, Graduate School of Medicine, University of Tokyo, Tokyo, Japan
Takashi Uzu
- Department of Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan
Motonobu Nishimura
- Department of Internal Medicine, Japan National Hospital Organization Chiba-East National Hospital, Chiba, Japan
Chikage Sato
- Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
Daisuke Ogawa
- Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
Hirofumi Makino
- Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
- Corresponding author at: Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan. Tel.: +81 86 235 7235; fax: +81 86 222 5214.
DNETT-Japan Study Group

Received 7 August 2009; accepted 28 September 2009. published online 05 November 2009.

Abstract

The prevalence of end-stage renal disease (ESRD) is uprising in the paralleled with the increase of chronic kidney disease (CKD) patients. Diabetic nephropathy (DN) is the most important underlying disease of CKD and a leading cause of ESRD in Japan. Intensified multifactorial intervention in patients with type 2 diabetes with microalbuminuria slows the progression to nephropathy, and progression of retinopathy and autonomic neuropathy. However, further studies are needed to establish the effect of intensified multifactorial treatment on DN with overt proteinuria. In this trial, doctors and co-medicals collaborate to treat the DN patients to prevent the deterioration of DN by multifactorial intensive therapy. Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan) is an open, randomized controlled trial to evaluate the efficacy of renal protection of multifactorial intensive therapy in type 2 diabetes patients with overt proteinuria (urinary albumin-to-creatinine ratio ≥300mg/g creatinine). The study has a targeted enrollment of 600 Japanese patients, and divided into two protocols by renal insufficiency (protocol A: serum creatinine: <1.2mg/dl in male and <1.0mg/dl in female, and protocol B: serum creatinine: 1.2–2.5mg/dl in male and 1.0–2.5mg/dl in female). The patients were allocated standard treatment or intensive multifactorial treatment. Intensive treatment was a stepwise implementation of behavior modification, pharmacological therapy targeting hyperglycaemia, hypertension, dyslipidaemia, and proteinuria. The primary outcome is the proteinuria in protocol A and the composite endpoint of time to the first occurrence of doubling of serum creatinine, ESRD (the need for chronic dialysis, or renal transplantation) or death in protocol B. The follow-up period is 5 years and the study ends in 2014.