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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008016
Receipt No. R000009432
Scientific Title Impacts of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension
Date of disclosure of the study information 2012/05/23
Last modified on 2015/06/01

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Basic information
Public title Impacts of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension
Acronym Spironolactone on albuminuria
Scientific Title Impacts of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension
Scientific Title:Acronym Spironolactone on albuminuria
Region
Japan

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

Objectives
Narrative objectives1 To clarify the efficacy of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension using ACE inhibitors and ARBs.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes of albuminuria
Key secondary outcomes 1.changes of serum potassium
2.changes of serum Cr, cystatin C, eGFR
3.changes of urinary iso-prostaglandin F2a
4.influences of TTKG
5.changes of serum and urinary CD147
6. changes of serum hs-CRP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Spironolactone 25mg/day for 8 weeks
Interventions/Control_2 Conventional therapy
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
30 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Type2 diabetes with nephropathy
2. proteinuria
3. Using anti-hypertensive drugs (ACE inhibitors/ARBs)
4. eGFR >30mL/min/1.73m2
Key exclusion criteria 1.History of using Spironolactone within 6 months
2.Type 1 diabetes
3.Uncontrolled Hypertension (systolic BP>180mmHg, diastolic>110mmHg)
4. Bilateral renal artery stenosis or renal artery stenosis with unilateral kidney
5.Myocardial infarction, unstable angina and stroke in the past 3 months
6. Heart failure (NYHA 3 or4 )
7. Potassium > 5.0 mEq/L
8. Cancer
9. liver dysfunction (AST or ALT >100 IU/L)
10. History of renal deterioration under ACE inhibitors/ARBs
11. Pregnancy and lactation
12. Unwillingness of entry
13. Patients with contraindication to study drugs
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Enyu Imai
Organization University of Nagoya Graduate School
of Medicine
Division name Nephrology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya,Aichi,Japan
TEL 0527442192
Email marus@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Maruyama
Organization University of Nagoya Graduate School of Medicine
Division name Nephrology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya,Aichi,Japan
TEL 0527442192
Homepage URL
Email marus@med.nagoya-u.ac.jp

Sponsor
Institute Department of Nephrology,
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Nephrology,
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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 名古屋大学医学部附属病院(愛知県)
岡山大学病院(岡山県)
滋賀医科大学附属病院(滋賀県)
金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25795029
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
2012 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
2014 Year 01 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 05 Month 23 Day
Last modified on
2015 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009432

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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