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

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 wit...

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Bibliographic Details
Published in:Clinical and experimental nephrology 2018-06, Vol.22 (3), p.591-596
Main Authors: 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
Format: Article
Language:English
Subjects:
Apheresis
Cholesterol
Clinical trials
Creatinine
Diabetes mellitus
Diabetic nephropathy
Dyslipidemia
End-stage renal disease
Excretion
Kidney diseases
Low density lipoprotein
Medicine
Medicine & Public Health
Metabolic disorders
Nephrology
Nephropathy
Original Article
Patients
Prognosis
Proteinuria
Quality of life
Renal function
Urology
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Summary: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.
ISSN:1342-1751
1437-7799
DOI:10.1007/s10157-017-1488-4