Miho Shimizu1, Kengo Furuichi1, Tadashi Toyama1, Tomoaki Funamoto1, Shinji Kitajima1, Akinori Hara1, Daisuke Ogawa2, Daisuke Koya3, Kenzo Ikeda4, Yoshitaka Koshino5, Yukie Kurokawa1,5, Hideharu Abe6, Kiyoshi Mori7, Masaaki Nakayama8, Yoshio Konishi9, Ken-Ichi Samejima10, Masaru Matsui10, Hiroyuki Yamauchi1, Tomohito Gohda11, Kei Fukami12, Daisuke Nagata13, Hidenori Yamazaki14, Yukio Yuzawa15, Yoshiki Suzuki16, Shouichi Fujimoto17, Shoichi Maruyama18, Sawako Kato18, Takero Naito19, Kenichi Yoshimura20, Hitoshi Yokoyama21, Takashi Wada22,23. 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. Division of Nephrology, Kanazawa University Hospital, Kanazawa, Japan. twada@m-kanazawa.jp. 23. Department of Nephrology and Laboratory Medicine, Kanazawa University Graduate School of Medical Sciences, 13-1 Takara-machi, Kanazawa, 920-8641, Japan. twada@m-kanazawa.jp.
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.
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.
Entities:
Keywords:
Changes in estimated glomerular filtration rate; Diabetic nephropathy; End-stage renal disease; Remission of macroalbuminuria; Surrogate endpoints
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