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Decline in estimated glomerular filtration rate is associated with risk of end-stage renal disease in type 2 diabetes with macroalbuminuria: an observational study from JDNCS
Authors:Miho Shimizu  Kengo Furuichi  Tadashi Toyama  Tomoaki Funamoto  Shinji Kitajima  Akinori Hara  Daisuke Ogawa  Daisuke Koya  Kenzo Ikeda  Yoshitaka Koshino  Yukie Kurokawa  Hideharu Abe  Kiyoshi Mori  Masaaki Nakayama  Yoshio Konishi  Ken-ichi Samejima  Masaru Matsui  Hiroyuki Yamauchi  Tomohito Gohda  Kei Fukami  Daisuke Nagata  Hidenori Yamazaki  Yukio Yuzawa  Yoshiki Suzuki  Shouichi Fujimoto  Shoichi Maruyama  Sawako Kato  Takero Naito  Kenichi Yoshimura  Hitoshi Yokoyama  Takashi Wada  Research Group of Diabetic Nephropathy  the Ministry of Health  Labour    Welfare of Japan  Japan Agency for Medical Research  Development
Affiliation:1.Division of Nephrology,Kanazawa University Hospital,Kanazawa,Japan;2.Department of Diabetic Nephropathy,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences,Okayama,Japan;3.Department of Diabetology and Endocrinology,Kanazawa Medical University,Uchinada,Japan;4.Izumigaoka Medical Clinic,Takaoka,Japan;5.Department of Internal Medicine,Mizuho Hospital,Tsubata,Japan;6.Department of Nephrology, Institute of Biomedical Sciences,Tokushima University Graduate School,Tokushima,Japan;7.Department of Medicine and Clinical Science,Kyoto University Graduate School of Medicine,Kyoto,Japan;8.Department of Nephrology and Hypertension,Fukushima Medical University School of Medicine,Fukushima,Japan;9.Department of Nephrology and Hypertension,Osaka City General Hospital,Osaka,Japan;10.First Department of Internal Medicine,Nara Medical University,Kashihara,Japan;11.Division of Nephrology, Department of Internal Medicine,Juntendo University Faculty of Medicine,Tokyo,Japan;12.Division of Nephrology, Department of Medicine,Kurume University School of Medicine,Kurume,Japan;13.Division of Nephrology, Department of Internal Medicine,Jichi Medical University,Shimotsuke,Japan;14.Second Department of Internal Medicine,University of Toyama,Toyama,Japan;15.Department of Nephrology,Fujita Health University School of Medicine,Toyoake,Japan;16.Health Administration Center,Niigata University,Niigata,Japan;17.Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine,University of Miyazaki,Miyazaki,Japan;18.Department of Nephrology,Nagoya University Graduate School of Medicine,Nagoya,Japan;19.Naito Medical Clinic,Toyama,Japan;20.Innovative Clinical Research Center,Kanazawa University Hospital,Kanazawa,Japan;21.Department of Nephrology,Kanazawa Medical University School of Medicine,Uchinada,Japan;22.Department of Nephrology and Laboratory Medicine,Kanazawa University Graduate School of Medical Sciences,Kanazawa,Japan
Abstract:

Background

There is increased interest in surrogate endpoints for clinical trials of chronic kidney disease.

Methods

In this nationwide observational study of 456 patients with type 2 diabetes and clinically suspected diabetic nephropathy followed for a median of 4.2 years, we evaluated the association between estimated glomerular filtration rate (eGFR) and albuminuria at baseline or during follow-up and risk of ESRD.

Results

Low eGFR (<60 mL/min/1.73 m2) and macroalbuminuria at enrollment were independently associated with risk of ESRD. In patients with macroalbuminuria, both ≤?50% change and ?50 to ?30% change in eGFR over 1 and 2 years were predictive of ESRD. The higher cut point (≥50% decline in eGFR) was more strongly predictive but less common. Remission of macroalbuminuria to normo-/microalbuminuria at 1 and 2 years was associated with a lower incidence of ESRD than no remission; however, it was not a determinant for ESRD independently of initial eGFR and initial protein-to-creatinine ratio.

Conclusion

These results suggest that a ≥30% decline in eGFR over 1 or 2 years adds prognostic information about risk for ESRD in patients with type 2 diabetes and macroalbuminuria, supporting the consideration of percentage decline in eGFR as a surrogate endpoint among macroalbuminuric cases in type 2 diabetes. On the other hand, our study suggests that additional analyses on the relationship between remission of macroalbuminuria and risk of ESRD are needed in type 2 diabetes.
Keywords:
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