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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022999
Receipt No. R000026509
Scientific Title anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
Date of disclosure of the study information 2016/07/03
Last modified on 2019/01/06

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Basic information
Public title anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
Acronym anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
Scientific Title anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
Scientific Title:Acronym anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
Region
Japan

Condition
Condition diabetic nephropathy
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we aim to prove the anti-albuminuric effect and safety of spironolactone 12.5mg once daily compared with controls in patients with diabetic nephropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes reduction in the rate of albuminuria at 24 weeks after administration.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 spironolactone 12.5mg once a day for 24 weeks.
Interventions/Control_2 control
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.patients with daiabetes who were 20year old or older
2.outpatients with diabetic nephropathy and albuminuria(more than 30 mg/g Cr)
3.eGFR more than 30mL/min/1.73m2
4.patients treated with RAS(renin-angiotensin system)blockade for more than 180 days
5.patients who were obtained written informed consent by free will after enough explanation.
Key exclusion criteria 1.eGFR less than 30mL/min/1.73m2
2.patients with potassium more than 5.0mEq/l
3.patients who have already treated with spironolactone
4.patients who have an allergy career to a study drug
5.pregnant woman and the woman whom I am nursing
6.other conditions that are considered inappropriate to participate by the investigators

Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ako Ooiwa
Organization Shinshu University Hospital
Division name Diabetes, Endocrinology and Metabolism
Zip code
Address 3-1-1 Asahi, Matumoto-shi, Nagano, JAPAN
TEL 0263-37-2686
Email akooiwa@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ako Ooiwa
Organization Shinshu University Hospital
Division name Diabetes, Endocrinology and Metabolism
Zip code
Address 3-1-1 Asahi, Matumoto-shi, Nagano, JAPAN
TEL 0263-37-2686
Homepage URL
Email akooiwa@shinshu-u.ac.jp

Sponsor
Institute Diabetes, Endocrinology and Metabolism,
Shinshu University Hospital
Institute
Department

Funding Source
Organization Diabetes, Endocrinology and Metabolism,
Shinshu University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Takeda Clinic of Internal Medicine
Miyamoto Clinic of Internal Medicine
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 03 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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 03 Day
Last modified on
2019 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026509

Research Plan
Registered date File name
2017/07/17 臨床研究「少量スピロノラクトン投与による糖尿病性腎症の尿中アルブミン減少効果」実施計画書第5版.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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