UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047516 |
|---|---|
| Receipt number | R000054167 |
| Scientific Title | LICENSE-Observational Study |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2024/04/19 09:24:07 |
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Basic information
Public title
LDL cholesterol apheresis treatment for diabetic nephropathy with severe urinary protein-Observational Study
Acronym
LICENSE-Observational Study
Scientific Title
LICENSE-Observational Study
Scientific Title:Acronym
LICENSE-ON
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From fiscal 2015, LDL apheresis therapy for diabetic nephropathy that presents with severe urinary protein associated with intractable hypercholesterolemia can be implemented as advanced medical treatment A, and it is possible to improve the life and renal prognosis of patients with treatment introduction. And safety were confirmed. This study was planned to observe the course and prognosis of new cases in which advanced medical care A is introduced and the long-term prognosis of cases introduced so far.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Introduced maintenance dialysis
Key secondary outcomes
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
Advanced medical care A Patients who have been treated according to the provisions of "LDL apheresis therapy".
Includes participants in the LICENSE study (jRCTs042180076).
Key exclusion criteria
-
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hara |
Organization
Kanazawa University
Division name
Department of Nephrology and Laboratory Medicine
Zip code
920-8641
Address
13-1,Takara-machi Kanazawa City
TEL
076-265-2000
hara-akinori@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Koshino |
Organization
Kanazawa University
Division name
Department of Nephrology and Laboratory Medicine
Zip code
920-8641
Address
13-1,Takara-machi Kanazawa City
TEL
076-265-2000
Homepage URL
koshino1307@gmail.com
Sponsor or person
Institute
Division of Nephrology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kaneka Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
13-1,Takara-machi Kanazawa City
Tel
076-265-2110
rinri@adm.kanazawa-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054167
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
