UMIN-CTR Clinical Trial

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
Email	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
Email	kokims-frz@okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038752