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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004779
Receipt No. R000005691
Scientific Title Treatment with propagermanium, a CCR2 inhibitor, for diabetic nephropathy
Date of disclosure of the study information 2011/01/04
Last modified on 2017/06/27

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Basic information
Public title Treatment with propagermanium, a CCR2 inhibitor, for diabetic nephropathy
Acronym Treatment with propagermanium for diabetic nephropathy
Scientific Title Treatment with propagermanium, a CCR2 inhibitor, for diabetic nephropathy
Scientific Title:Acronym Treatment with propagermanium for diabetic nephropathy
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of propagermanium on diabetic nephropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Urinary albumin excretion
Urinary protein excretion
Key secondary outcomes Blood pressure, kidney function,
Blood glucose, HbAc1, lipid profile,
White blood cells, high-sensitive CRP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group
Interventions/Control_2 Propagermanium group
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
35 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria -Type 2 diabetes and its duration equal or longer than 5 years
-Persistent microalbuminuria or proteinuria
-Estimated GFR equal or greater than 30ml/min/1.73m2
-HbA1c < 10%
-BMI 19-40 kg/m2
Key exclusion criteria -Positive for hepatitis viral markers
-Severe liver dysfunction
-Past history of jaundice
-Severe kidney dysfunction
-Past history of arteriosclerosis obliterance, myocardial infarction or cerebral infarction within 3 month before enrollment
-Age equal or older than 75 years
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Wada
Organization Kanazawa University
Division name Department of Nephrology and Laboratory Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2000
Email twada@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Wada
Organization Kanazawa University
Division name Department of Nephrology and Laboratory Medicine
Zip code
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 Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 04 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 Completed
Date of protocol fixation
2010 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2017 Year 05 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 22 Day
Last modified on
2017 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005691

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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