UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033985 |
|---|---|
| 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 |
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Basic information
Public title
Excreted urinary glycans Analysis and diagnosis of kidney disease without renal Tissue specimens(Extant) Study -Multicenter Prospective study-
Acronym
Extant Prospective Study
Scientific Title
Excreted urinary glycans Analysis and diagnosis of kidney disease without renal Tissue specimens(Extant) Study -Multicenter Prospective study-
Scientific Title:Acronym
Extant Prospective Study
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical performance of urinary diagnostic kit for differenciating IgA nephropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
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)
Key secondary outcomes
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
1. Patients who decline the entry of this study.
2. Patients who are regarded as inappropriate for joining this study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Wada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7235
junwada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Mise |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7235
Homepage URL
kokims-frz@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
AMED(Japan Agency for Medical Research and Development)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
GlycoTechnica
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital, Center for Innovative Clinical Medicine, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
Tel
086-235-6503
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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.
Management information
Registered date
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038752
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| Registered date | File name |
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