UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008016 |
|---|---|
| Receipt number | 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 16:20:11 |
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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
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
marus@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Nephrology,
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009432
