UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004779
Receipt number 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 09:42:36

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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 or person

Institute

Division of Nephrology, Kanazawa University Hospital

Institute

Department

Personal name



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

Value
https://center6.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