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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008521
Receipt No. R000010014
Scientific Title The effect of Eplerenone the Renal Insulin Resistance syndrome
Date of disclosure of the study information 2012/07/24
Last modified on 2020/02/26

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Basic information
Public title The effect of Eplerenone the Renal Insulin Resistance syndrome
Acronym The effect of Eplerenone on the Renal Insulin Resistance syndrome
Scientific Title The effect of Eplerenone the Renal Insulin Resistance syndrome
Scientific Title:Acronym The effect of Eplerenone on the Renal Insulin Resistance syndrome
Region
Japan

Condition
Condition Chronic Kidney Disease
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of Eplerenone on Renal Insulin Resistance syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes HOMA-IR, rate of change in eGFR, incidence of CVD, mortality rate
Key secondary outcomes ABI, PWV, IMT, markers of tubular damage,
TP/Cr, BNP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 control group 1
medication of pracebo for 3 years
Interventions/Control_2 intervention group 1
medication of Eplerenone(25mg/day) for 3 years
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
25 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.CKD patient
2.HOMA-IR1.6
3.Serum Aldosterone level>150pg/ml
Key exclusion criteria 1.diabetes mellitus
2.Serum creatinine level>2.0mg/dl
3.Serum potasium level>5mEq/L
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Minakuchi
Organization The hospital of Keio University
Division name internal medicine
Zip code 1608582
Address Shinanomachi 35, shinjuku,Tokyo,Japan
TEL 011-81-3-3353-1211
Email minakuchi19042078@yahoo.co.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Minakuchi
Organization The hospital of Keio University
Division name internal medicine
Zip code 1608582
Address Shinanomachi 35, shinjuku,Tokyo,Japan
TEL 011-81-3-3353-1211
Homepage URL
Email minakuchi19042078@yahoo.co.jp

Sponsor
Institute The hospital of Keio University
Institute
Department

Funding Source
Organization Grants-in-aid for scientific research of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The hospital of Keio University
Address shinanomachi 35, shinjuku, Tokyo, Japan
Tel 011-81-3-3353-1211
Email med-rinri-jimu@adst.keio.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
2012 Year 07 Month 24 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
2011 Year 07 Month 01 Day
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 24 Day
Last modified on
2020 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010014

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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