Clinical and Experimental Nephrology

, Volume 22, Issue 3, pp 591–596 | Cite as

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
Original article
  • 139 Downloads

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.

Keywords

Diabetic nephropathy LDL Apheresis Proteinuria 

Notes

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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Copyright information

© Japanese Society of Nephrology 2017

Authors and Affiliations

  • Takashi Wada
    • 1
    • 2
  • Eri Muso
    • 3
  • Shoichi Maruyama
    • 4
  • Akinori Hara
    • 2
  • Kengo Furuichi
    • 2
  • Kenichi Yoshimura
    • 5
  • Mariko Miyazaki
    • 6
  • Eiichi Sato
    • 7
  • Masanori Abe
    • 8
  • Yugo Shibagaki
    • 9
  • Ichiei Narita
    • 10
  • Hitoshi Yokoyama
    • 11
  • Noriko Mori
    • 12
  • Yukio Yuzawa
    • 13
  • Takeshi Matsubara
    • 14
  • Tatsuo Tsukamoto
    • 3
  • Jun Wada
    • 15
  • Takafumi Ito
    • 16
  • Kosuke Masutani
    • 17
  • Kazuhiko Tsuruya
    • 18
  • Shoichi Fujimoto
    • 19
  • Akihiro Tsuda
    • 20
  • Hitoshi Suzuki
    • 21
  • Kenji Kasuno
    • 22
  • Yoshio Terada
    • 23
  • Takeshi Nakata
    • 24
  • Noriaki Iino
    • 25
  • Shuzo Kobayashi
    • 26
  1. 1.Department of Nephrology and Laboratory Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Faculty of MedicineKanazawa UniversityKanazawaJapan
  2. 2.Division of NephrologyKanazawa University HospitalKanazawaJapan
  3. 3.Department of Nephrology and DialysisKitano Hospital, Tazuke Kofukai Medical Research InstituteOsakaJapan
  4. 4.Department of NephrologyNagoya University Graduate School of MedicineNagoyaJapan
  5. 5.Innovative Clinical Research Center (iCREK)Kanazawa University HospitalKanazawaJapan
  6. 6.Division of Nephrology, Endocrinology and Vascular MedicineTohoku University Graduate School of MedicineSendaiJapan
  7. 7.Division of Nephrology, Department of Internal MedicineShinmatsudo Central General HospitalMatsudoJapan
  8. 8.Divisions of Nephrology, Hypertension and Endocrinology, Department of Internal MedicineNihon University School of MedicineTokyoJapan
  9. 9.Division of Nephrology and Hypertension, Department of Internal MedicineSt Marianna University School of MedicineKanagawaJapan
  10. 10.Division of Clinical Nephrology and RheumatologyNiigata University Graduate School of Medical and Dental SciencesNiigataJapan
  11. 11.Department of Nephrology, School of MedicineKanazawa Medical UniversityUchinadaJapan
  12. 12.Department of NephrologyShizuoka General HospitalShizuokaJapan
  13. 13.Department of NephrologyFujita Health University School of MedicineToyoakeJapan
  14. 14.Department of NephrologyKyoto UniversityKyotoJapan
  15. 15.Department of Nephrology, Rheumatology, Endocrinology and MetabolismOkayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesOkayamaJapan
  16. 16.Division of NephrologyShimane University HospitalIzumoJapan
  17. 17.Division of Nephrology and Rheumatology, Department of Internal Medicine, Faculty of MedicineFukuoka UniversityFukuokaJapan
  18. 18.Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical SciencesKyushu UniversityFukuokaJapan
  19. 19.Department of Hemovascular Medicine and Artificial Organs, Faculty of MedicineUniversity of MiyazakiMiyazakiJapan
  20. 20.Department of Metabolism, Endocrinology and Molecular MedicineOsaka City University Graduate School of MedicineOsakaJapan
  21. 21.Department of NephrologyJuntendo University Faculty of MedicineTokyoJapan
  22. 22.Division of Nephrology, Department of General MedicineUniversity of Fukui School of Medical SciencesFukuiJapan
  23. 23.Department of Endocrinology, Metabolism and Nephrology, Kochi Medical SchoolKochi UniversityKochiJapan
  24. 24.Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of MedicineOita UniversityYufuJapan
  25. 25.Department of NephrologyUonuma Institute of Community Medicine, Niigata University Medical and Dental HospitalNiigataJapan
  26. 26.Department of Kidney Disease and Transplant CenterShonan Kamakura General HospitalKamakuraJapan

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