UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014875 |
|---|---|
| Receipt number | R000017299 |
| Scientific Title | LDL cholesterol apheresis treatment for diabetic nephropathy with severe urinary protein: a multicenter prospective study |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2019/05/15 11:53:44 |
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Basic information
Public title
LDL cholesterol apheresis treatment for diabetic nephropathy with severe
urinary protein: a multicenter prospective study
Acronym
LICENSE study
Scientific Title
LDL cholesterol apheresis treatment for diabetic nephropathy with severe
urinary protein: a multicenter prospective study
Scientific Title:Acronym
LICENSE study
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of LDL cholesterol apheresis in diabetic nephropathy with severe hypercholesterolemia and proteinuria
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of achievement of more than 30% decrease in urinary protein/urinary creatinine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LDL apheresis
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Clinically diagnosed diabetic nephropathy fulfills the following criteria within 3 months before enrollment;
-urinary protein/urinary creatinine equal or more than 3g/gCr or 3g/day
-serum creatinine less than 2mg/dL
2)Age matched or older than 20 years and younger than 75 years
Key exclusion criteria
-Dialysis patients
-Post renal transplantation or nephrectomy
-Past history undergoing LDL apheresis
-Undergoing surgical procedure including revascularization within 6 month before enrollment
-proliferating diabetic retinopathy or severe diabetic neuropathy
-Peripheral artery disease (Rutherford class 5 or more) or post amputation
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Wada |
Organization
Kanazawa University
Division name
Department of Nephrology and Laboratory Medicine
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2000
twada@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Wada |
Organization
Kanazawa University
Division name
Department of Nephrology and Laboratory Medicine
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2000
Homepage URL
lab-med@med.kanazawa-u.ac.jp
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
Institutional review board
Address
13-1 Takara-machi, Kanazawa, Ishikawa
Tel
076-265-2090
hpsangak@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
| 2014 | 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
42
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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Completed Transfer to other database
Management information
Registered date
| 2014 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017299
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
