TY - JOUR
T1 - 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
AU - Wada, Takashi
AU - Muso, Eri
AU - Maruyama, Shoichi
AU - Hara, Akinori
AU - Furuichi, Kengo
AU - Yoshimura, Kenichi
AU - Miyazaki, Mariko
AU - Sato, Eiichi
AU - Abe, Masanori
AU - Shibagaki, Yugo
AU - Narita, Ichiei
AU - Yokoyama, Hitoshi
AU - Mori, Noriko
AU - Yuzawa, Yukio
AU - Matsubara, Takeshi
AU - Tsukamoto, Tatsuo
AU - Wada, Jun
AU - Ito, Takafumi
AU - Masutani, Kosuke
AU - Tsuruya, Kazuhiko
AU - Fujimoto, Shoichi
AU - Tsuda, Akihiro
AU - Suzuki, Hitoshi
AU - Kasuno, Kenji
AU - Terada, Yoshio
AU - Nakata, Takeshi
AU - Iino, Noriaki
AU - Kobayashi, Shuzo
N1 - Publisher Copyright:
© 2017, Japanese Society of Nephrology.
PY - 2018/6/1
Y1 - 2018/6/1
N2 - 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.
AB - 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.
KW - Apheresis
KW - Diabetic nephropathy
KW - LDL
KW - Proteinuria
UR - http://www.scopus.com/inward/record.url?scp=85032500747&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85032500747&partnerID=8YFLogxK
U2 - 10.1007/s10157-017-1488-4
DO - 10.1007/s10157-017-1488-4
M3 - Article
C2 - 29080119
AN - SCOPUS:85032500747
SN - 1342-1751
VL - 22
SP - 591
EP - 596
JO - Clinical and Experimental Nephrology
JF - Clinical and Experimental Nephrology
IS - 3
ER -
