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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029336
Receipt No. R000033529
Scientific Title EXcreTed urinary glycans ANalysis and diagnosis of kidney disease without renal Tissue specimens(Extant)Study
Date of disclosure of the study information 2017/10/01
Last modified on 2019/05/08

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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 Unpublished

Result
URL related to results and publications
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 No longer recruiting
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
2017 Year 12 Month 01 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
2019 Year 05 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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