Unique ID issued by UMIN | UMIN000033985 |
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Receipt number | R000038752 |
Scientific Title | Excreted urinary glycans Analysis and diagnosis of kidney disease without renal Tissue specimens(Extant) Study -Multicenter Prospective study- |
Date of disclosure of the study information | 2019/01/01 |
Last modified on | 2020/09/04 13:20:32 |
Excreted urinary glycans Analysis and diagnosis of kidney disease without renal Tissue specimens(Extant) Study -Multicenter Prospective study-
Extant Prospective Study
Excreted urinary glycans Analysis and diagnosis of kidney disease without renal Tissue specimens(Extant) Study -Multicenter Prospective study-
Extant Prospective Study
Japan |
IgA nephropathy
Nephrology |
Others
NO
To investigate the clinical performance of urinary diagnostic kit for differenciating IgA nephropathy
Efficacy
Confirmatory
Others
Not applicable
Clinical performance for differentiating IgA nephropathy from other renal diseases by the combination of urinary glycan profiling and clinical tests (hematuria, proteinuria, serum IgA) (Sensitivity and Specificity)
1) Clinical performance for differentiating IgA nephropathy from other renal diseases by the combination of urinary glycan profiling and clinical tests (hematuria, proteinuria, serum IgA) (Accuracy and ROC-AUC)
2) Clinical performance for differentiating IgA nephropathy from other renal diseases by urinary glycan profiling (Sensitivity and Specificity)
3) Clinical performance for differentiating IgA nephropathy from other primary glomerular diseases by the combination of urinary glycan profiling and clinical tests (hematuria, proteinuria, serum IgA) (Sensitivity, Specificity, Accuracy, and ROC-AUC)
4) Clinical performance for differentiating the participants with IgA nephropathy from with other renal diseases in 4 subgroups defined by 2 factors, eGFR (>= or <30 mL/min/1.73m2), and proteinuria (>= or <0.5 g/gCr), by the combination of urinary glycan profiling and clinical tests (Sensitivity, Specificity, Accuracy, and ROC-AUC)
Observational
Not applicable |
Not applicable |
Male and Female
Patients with renal biopsy at 16 institutions (Okayama university hospital, Okayama Okayama Saiseikai General Hospital, National Hospital Organization Okayama Medical Center, Kurashiki Central Hospital, Japanese Red Cross Okayama Hospital, Japanese Red Cross Society Himeji Hospital, Cugoku Central Hospital, Hiroshima City Hiroshima Citizens Hospital, Onomichi Municipal Hospital, Kousei General Hospital, Ehime Prefectural Central Hospital, Matsuyama Shimin Hospital, Mitoyo General Hospital, Kagawa Prefectural Central Hospital, Kagawa Rosai Hospital, and Kochi Health Sciences Center) between January 2019 and December 2019.
1. Patients who decline the entry of this study.
2. Patients who are regarded as inappropriate for joining this study.
400
1st name | Jun |
Middle name | |
Last name | Wada |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
700-8558
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
086-235-7235
junwada@okayama-u.ac.jp
1st name | Koki |
Middle name | |
Last name | Mise |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
700-8558
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
086-235-7235
kokims-frz@okayama-u.ac.jp
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
AMED(Japan Agency for Medical Research and Development)
Japanese Governmental office
Japan
GlycoTechnica
Okayama University Hospital, Center for Innovative Clinical Medicine, Ethics Committee
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
086-235-6503
mae6605@adm.okayama-u.ac.jp
NO
岡山大学病院(岡山県)、岡山済生会総合病院(岡山県)、岡山医療センター(岡山県)、倉敷中央病院(岡山県)、岡山赤十字病院(岡山県)、姫路赤十字病院(兵庫県)、中国中央病院(広島県)、広島市民病院(広島県)、尾道市民病院(広島県)、興生総合病院(広島県)、愛媛県立中央病院(愛媛県)、松山市民病院(愛媛県)、三豊総合病院(香川県)、香川県立中央病院(香川県)、香川労災病院(香川県)、高知医療センター(高知県)
2019 | Year | 01 | Month | 01 | Day |
Unpublished
No longer recruiting
2018 | Year | 08 | Month | 28 | Day |
2018 | Year | 11 | Month | 16 | Day |
2019 | Year | 01 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
Among enrolled patients with renal biopsy, clinical performance of urinary diagnostic kit for diagnosing IgA nephropathy is assessed based on the diagnostic algorism derived from the results of Extant retrospective study.
2018 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038752
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