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
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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.
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.
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.
This study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathy patients with severe proteinuria and dyslipidemia.
KeywordsDiabetic nephropathy LDL Apheresis Proteinuria
Compliance with ethical standards
Conflict of interest
The authors have declared that no conflict of interest exists.
Human and animal rights
This study will be conducted in accordance with the International Committee for Harmonization-Good Clinical Practice (ICH-GCP) guideline and the Declaration of Helsinki. The study protocol was approved by the institutional review boards of all participating institutions [the medical ethics committee of Kanazawa University, Approval no. 5933)]. Informed consent will be obtained from all patients before registration. This study was registered with UMIN Clinical Trials Registry (UMIN000014875). This article does not contain any studies with animals performed by any of the authors. While this will be a physician-led study, quality control such as data management and statistical analysis, reliability assurance such as supervision and safety and efficacy board operation, as well as some or all of the costs associated with duties required to implement the clinical study will be provided by Kaneka Corporation. However, Kaneka Corporation will not be involved in the implementation of this study or collecting, analyzing or interpreting the results or the publication of results. Moreover, the implementation of this clinical study will not deprive the subjects of any rights or benefits. These study management and operational functions will be overseen by the Hokuriku Clinical Research Supporting Center after concluding a contract related to clinical study support and all aspects including costs will be managed. The study coordinator of this study will report any necessary information to the Kanazawa University conflict of interest committee in accordance with the Kanazawa University Clinical Study Conflict of Interest Management Policy to undergo screening and receive approval.
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