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Rationale and study design of a clinical trial to assess the effects of LDL apheresis on proteinuria in diabetic patients with severe proteinuria and dyslipidemia
Authors:Takashi Wada  Eri Muso  Shoichi Maruyama  Akinori Hara  Kengo Furuichi  Kenichi Yoshimura  Mariko Miyazaki  Eiichi Sato  Masanori Abe  Yugo Shibagaki  Ichiei Narita  Hitoshi Yokoyama  Noriko Mori  Yukio Yuzawa  Takeshi Matsubara  Tatsuo Tsukamoto  Jun Wada  Takafumi Ito  Kosuke Masutani  Kazuhiko Tsuruya  Shoichi Fujimoto  Akihiro Tsuda  Hitoshi Suzuki  Kenji Kasuno  Yoshio Terada  Takeshi Nakata  Noriaki Iino  Shuzo Kobayashi
Affiliation:1.Department of Nephrology and Laboratory Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Faculty of Medicine,Kanazawa University,Kanazawa,Japan;2.Division of Nephrology,Kanazawa University Hospital,Kanazawa,Japan;3.Department of Nephrology and Dialysis,Kitano Hospital, Tazuke Kofukai Medical Research Institute,Osaka,Japan;4.Department of Nephrology,Nagoya University Graduate School of Medicine,Nagoya,Japan;5.Innovative?Clinical Research?Center?(iCREK),Kanazawa University Hospital,Kanazawa,Japan;6.Division of Nephrology, Endocrinology and Vascular Medicine,Tohoku University Graduate School of Medicine,Sendai,Japan;7.Division of Nephrology, Department of Internal Medicine,Shinmatsudo Central General Hospital,Matsudo,Japan;8.Divisions of?Nephrology, Hypertension and Endocrinology, Department of Internal Medicine,Nihon University School of Medicine,Tokyo,Japan;9.Division of Nephrology and Hypertension, Department of Internal Medicine,St Marianna University School of Medicine,Kanagawa,Japan;10.Division of Clinical Nephrology and Rheumatology,Niigata University Graduate School of Medical and Dental Sciences,Niigata,Japan;11.Department of Nephrology, School of Medicine,Kanazawa Medical University,Uchinada,Japan;12.Department of Nephrology,Shizuoka General Hospital,Shizuoka,Japan;13.Department of Nephrology,Fujita Health University School of Medicine,Toyoake,Japan;14.Department of Nephrology,Kyoto University,Kyoto,Japan;15.Department of Nephrology, Rheumatology, Endocrinology and Metabolism,Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences,Okayama,Japan;16.Division of Nephrology,Shimane University Hospital,Izumo,Japan;17.Division of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of Medicine,Fukuoka University,Fukuoka,Japan;18.Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences,Kyushu University,Fukuoka,Japan;19.Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine,University of Miyazaki,Miyazaki,Japan;20.Department of Metabolism, Endocrinology and Molecular Medicine,Osaka City University Graduate School of Medicine,Osaka,Japan;21.Department of Nephrology,Juntendo University Faculty of Medicine,Tokyo,Japan;22.Division of Nephrology, Department of General Medicine,University of Fukui School of Medical Sciences,Fukui,Japan;23.Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School,Kochi University,Kochi,Japan;24.Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of Medicine,Oita University,Yufu,Japan;25.Department of Nephrology,Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital,Niigata,Japan;26.Department of Kidney Disease and Transplant Center,Shonan Kamakura General Hospital,Kamakura,Japan
Abstract:

Background

Diabetic nephropathy is a leading cause of end-stage kidney disease in the world. Although various types of treatment for diabetes, hypertension and dyslipidemia have improved prognosis and quality of life in patients with diabetic nephropathy, there still exist some diabetic patients with severe proteinuria showing poor prognosis. This clinical trial, LICENSE, aims to confirm the impact of LDL apheresis on proteinuria exhibiting hyporesponsiveness to treatment.

Methods

This ongoing trial is a multicenter, prospective study of diabetic patients with severe proteinuria. The objective is to examine the impact of LDL apheresis on proteinuria in patients with diabetic nephropathy. The other subject is to investigate safety of LDL apheresis in these patients.

Results

The subjects consist of diabetic patients with serum creatinine (Cr) levels below 2 mg/dL who present severe proteinuria above 3 g/g Cr or 3 g/day and LDL cholesterol above 120 mg/dL. The target number of registered patients will be 35 patients. Urinary protein excretion and renal function will be observed for 24 weeks after the treatment of LDL apheresis.

Conclusion

This study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathy patients with severe proteinuria and dyslipidemia.
Keywords:
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