UMIN-CTR Clinical Trial

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
Last 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
Email	twada@m-kanazawa.jp

Public contact
1st 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
Email	lab-med@med.kanazawa-u.ac.jp

Sponsor
Institute	Division of Nephrology, Kanazawa University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017299