UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029336 |
|---|---|
| Receipt number | 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 | 2022/01/05 13:28:31 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033529
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| Registered date | File name |
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