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

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 & 8 others Shoichi Fujimoto, Akihiro Tsuda, Hitoshi Suzuki, Kenji Kasuno, Yoshio Terada, Takeshi Nakata, Noriaki Iino, Shuzo Kobayashi

研究成果: Article

抄録

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.

元の言語English
ページ(範囲)591-596
ページ数6
ジャーナルClinical and Experimental Nephrology
22
発行部数3
DOI
出版物ステータスPublished - 01-06-2018

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Blood Component Removal
Dyslipidemias
Proteinuria
Clinical Trials
Diabetic Nephropathies
Creatinine
Safety
oxidized low density lipoprotein
LDL Cholesterol
Multicenter Studies
Chronic Kidney Failure
Therapeutics
Quality of Life
Prospective Studies
Hypertension

All Science Journal Classification (ASJC) codes

  • Physiology
  • Nephrology
  • Physiology (medical)

これを引用

Wada, Takashi ; Muso, Eri ; Maruyama, Shoichi ; Hara, Akinori ; Furuichi, Kengo ; Yoshimura, Kenichi ; Miyazaki, Mariko ; Sato, Eiichi ; Abe, Masanori ; Shibagaki, Yugo ; Narita, Ichiei ; Yokoyama, Hitoshi ; Mori, Noriko ; Yuzawa, Yukio ; Matsubara, Takeshi ; Tsukamoto, Tatsuo ; Wada, Jun ; Ito, Takafumi ; Masutani, Kosuke ; Tsuruya, Kazuhiko ; Fujimoto, Shoichi ; Tsuda, Akihiro ; Suzuki, Hitoshi ; Kasuno, Kenji ; Terada, Yoshio ; Nakata, Takeshi ; Iino, Noriaki ; Kobayashi, Shuzo. / 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. :: Clinical and Experimental Nephrology. 2018 ; 巻 22, 番号 3. pp. 591-596.
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title = "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",
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.",
author = "Takashi Wada and Eri Muso and Shoichi Maruyama and Akinori Hara and Kengo Furuichi and Kenichi Yoshimura and Mariko Miyazaki and Eiichi Sato and Masanori Abe and Yugo Shibagaki and Ichiei Narita and Hitoshi Yokoyama and Noriko Mori and Yukio Yuzawa and Takeshi Matsubara and Tatsuo Tsukamoto and Jun Wada and Takafumi Ito and Kosuke Masutani and Kazuhiko Tsuruya and Shoichi Fujimoto and Akihiro Tsuda and Hitoshi Suzuki and Kenji Kasuno and Yoshio Terada and Takeshi Nakata and Noriaki Iino and Shuzo Kobayashi",
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Wada, T, Muso, E, Maruyama, S, Hara, A, Furuichi, K, Yoshimura, K, Miyazaki, M, Sato, E, Abe, M, Shibagaki, Y, Narita, I, Yokoyama, H, Mori, N, Yuzawa, Y, Matsubara, T, Tsukamoto, T, Wada, J, Ito, T, Masutani, K, Tsuruya, K, Fujimoto, S, Tsuda, A, Suzuki, H, Kasuno, K, Terada, Y, Nakata, T, Iino, N & Kobayashi, S 2018, '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', Clinical and Experimental Nephrology, 巻. 22, 番号 3, pp. 591-596. https://doi.org/10.1007/s10157-017-1488-4

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. / Wada, Takashi; Muso, Eri; Maruyama, Shoichi; Hara, Akinori; Furuichi, Kengo; Yoshimura, Kenichi; Miyazaki, Mariko; Sato, Eiichi; Abe, Masanori; Shibagaki, Yugo; Narita, Ichiei; Yokoyama, Hitoshi; Mori, Noriko; Yuzawa, Yukio; Matsubara, Takeshi; Tsukamoto, Tatsuo; Wada, Jun; Ito, Takafumi; Masutani, Kosuke; Tsuruya, Kazuhiko; Fujimoto, Shoichi; Tsuda, Akihiro; Suzuki, Hitoshi; Kasuno, Kenji; Terada, Yoshio; Nakata, Takeshi; Iino, Noriaki; Kobayashi, Shuzo.

:: Clinical and Experimental Nephrology, 巻 22, 番号 3, 01.06.2018, p. 591-596.

研究成果: Article

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

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.

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U2 - 10.1007/s10157-017-1488-4

DO - 10.1007/s10157-017-1488-4

M3 - Article

VL - 22

SP - 591

EP - 596

JO - Clinical and Experimental Nephrology

JF - Clinical and Experimental Nephrology

SN - 1342-1751

IS - 3

ER -