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: |
BackgroundThere is increased interest in surrogate endpoints for clinical trials of chronic kidney disease.MethodsIn 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.ResultsLow 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.ConclusionThese 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. |