UMIN-CTR Clinical Trial

Basic information
Public title	EXcreTed urinary glycans ANalysis and diagnosis of kidney disease without renal Tissue specimens(Extant)Study
Acronym	Extant Retrospective Study
Scientific Title	EXcreTed urinary glycans ANalysis and diagnosis of kidney disease without renal Tissue specimens(Extant)Study
Scientific Title:Acronym	Extant Retrospective Study
Region	Japan

Condition
Condition	Kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of new biomarkers to make a diagnosis of IgA nephropathy by glycan profiling
Basic objectives2	Others
Basic objectives -Others	Identification of new biomarkers to make a diagnosis of other kideny diseases by glycan profiling
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Differenciating IgA nephropathy from other kideny disease and/or non-kidney disease
Key secondary outcomes	I Urinary glycan biomarker for investigatiing differencial diagnosis 1. To differenciate IgA nephropathy from other kideny disease 2. To differenciate diabetic nephropathy from other kideny disease 3. To differenciate nephrosclerosis from other kideny disease 4. To differenciate obesity-related glomerulopathy from other kideny disease 5. To differenciate membranous nephropathy from other kideny disease 6. To differenciate minimal change disease from other kideny disease 7. To differenciate Lupus nephropathy from other kideny disease 8. To differenciate ANCA-associated vasculitis from other kideny disease II Investigation of the relationship of urinary glycan profile with renal outcome, cardiovascular event, and mortality. 1. eGFR 30-40% decline from baseline 2. eGFR decline > 3-5 ml/min/1.73m2/year 3. Commencement of dialysis or renal transplantation because of end stage renal disease 4. Development of albuminuric stage 5. Mortality 6. Cardiovascular event for admission III. Examination of the association between histopathologic parameters and urinary glycan excretion

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 1. Patients who underwent renal biopsy from December 1, 2000 to September 30, 2017 and were diagnosed with kidney disease. 2. Patients who were enrolled into previous clinical studies of our department(No: 1009 and No: 1509-005[2063]). Healthy volunteers 1 1. Donors of kidney transplantation in our hospital since July 1, 2017 2. Donors without urine abnormalities such as hematuria and proteinuria. 3. Donors who are not diagnosed with any kidney disease in the results of 0 hour-renal biopsy. 4. Donors who agree to keep their blood and urine sample in OKADAI BIOBANK (Biobank of Okayama university hospital). Healthy volunteers 2 1. People who were registered as healthy volunteers in a clinical study (No: 1702-026, Okayama university hospital) 2. People without urine abnormalities (hematuria and proteinuria) 3. People without metabolic syndrome
Key exclusion criteria	Patients with renal biopsy Patients who withdraw the agreement of previous clinical studies of our department (No: 1009 and No: 1509-005[2063]). Healthy volunteers 1 and 2 People who decline the entry of this study.
Target sample size	460

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
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	GlycoTechnica
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, 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)

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.karger.com/Article/Abstract/520998
Number of participants that the trial has enrolled	525
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	Main results already published
Date of protocol fixation	2017 Year 09 Month 26 Day
Date of IRB	2017 Year 10 Month 20 Day
Anticipated trial start date	2017 Year 10 Month 26 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2017 Year 09 Month 28 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033529