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; Shoichi Fujimoto; Akihiro Tsuda; Hitoshi Suzuki; Kenji Kasuno; Yoshio Terada; Takeshi Nakata; Noriaki Iino; Shuzo Kobayashi

doi: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

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 TsuruyaShoichi Fujimoto, Akihiro Tsuda, Hitoshi Suzuki, Kenji Kasuno, Yoshio Terada, Takeshi Nakata, Noriaki Iino, Shuzo Kobayashi

Research output: Contribution to journal › Article

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.

Original language	English
Pages (from-to)	591-596
Number of pages	6
Journal	Clinical and Experimental Nephrology
Volume	22
Issue number	3
DOIs	https://doi.org/10.1007/s10157-017-1488-4
Publication status	Published - Jun 1 2018

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Keywords

Apheresis
Diabetic nephropathy
LDL
Proteinuria

ASJC Scopus subject areas

Physiology
Nephrology
Physiology (medical)

Cite this

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., ... 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, 22(3), 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.

In: Clinical and Experimental Nephrology, Vol. 22, No. 3, 01.06.2018, p. 591-596.

Research output: Contribution to journal › Article

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, vol. 22, no. 3, pp. 591-596. https://doi.org/10.1007/s10157-017-1488-4

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. In: Clinical and Experimental Nephrology. 2018 ; Vol. 22, No. 3. pp. 591-596.

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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.",

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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.

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KW - Apheresis

KW - Diabetic nephropathy

KW - LDL

KW - Proteinuria

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10.1007/s10157-017-1488-4