TY - JOUR
T1 - Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan)
T2 - Rationale and study design
AU - Shikata, Kenichi
AU - Haneda, Masakazu
AU - Koya, Daisuke
AU - Suzuki, Yoshiki
AU - Tomino, Yasuhiko
AU - Yamada, Kenichi
AU - Maeda, Shiro
AU - Kawakami, Norito
AU - Uzu, Takashi
AU - Nishimura, Motonobu
AU - Sato, Chikage
AU - Ogawa, Daisuke
AU - Makino, Hirofumi
N1 - Funding Information:
This study was supported by a Grant-in-Aid for Scientific Research ( 200624010B to H. Makino) from the Ministry of Health, Labour and Welfare of Japan .
Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2010/2
Y1 - 2010/2
N2 - 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 ≥300 mg/g creatinine). The study has a targeted enrollment of 600 Japanese patients, and divided into two protocols by renal insufficiency (protocol A: serum creatinine: <1.2 mg/dl in male and <1.0 mg/dl in female, and protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/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.
AB - 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 ≥300 mg/g creatinine). The study has a targeted enrollment of 600 Japanese patients, and divided into two protocols by renal insufficiency (protocol A: serum creatinine: <1.2 mg/dl in male and <1.0 mg/dl in female, and protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/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.
KW - Cardiovascular event
KW - Diabetic nephropathy
KW - Intensive multifactorial intervention
KW - Overt proteinuria
KW - Type 2 diabetes
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U2 - 10.1016/j.diabres.2009.09.025
DO - 10.1016/j.diabres.2009.09.025
M3 - Article
C2 - 19889469
AN - SCOPUS:74449084429
VL - 87
SP - 228
EP - 232
JO - Diabetes Research and Clinical Practice
JF - Diabetes Research and Clinical Practice
SN - 0168-8227
IS - 2
ER -