Unique ID issued by UMIN | UMIN000008016 |
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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 |
Impacts of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension
Spironolactone on albuminuria
Impacts of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension
Spironolactone on albuminuria
Japan |
Diabetic nephropathy
Endocrinology and Metabolism | Nephrology |
Others
NO
To clarify the efficacy of spironolactone on albuminuria in patients with diabetic nephropathy and hypertension using ACE inhibitors and ARBs.
Efficacy
Confirmatory
Pragmatic
Phase IV
Changes of albuminuria
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
Spironolactone 25mg/day for 8 weeks
Conventional therapy
30 | years-old | <= |
75 | years-old | > |
Male and Female
1. Type2 diabetes with nephropathy
2. proteinuria
3. Using anti-hypertensive drugs (ACE inhibitors/ARBs)
4. eGFR >30mL/min/1.73m2
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
50
1st name | |
Middle name | |
Last name | Enyu Imai |
University of Nagoya Graduate School
of Medicine
Nephrology
65 Tsurumai-cho, Showa-ku, Nagoya,Aichi,Japan
0527442192
marus@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Shoichi Maruyama |
University of Nagoya Graduate School of Medicine
Nephrology
65 Tsurumai-cho, Showa-ku, Nagoya,Aichi,Japan
0527442192
marus@med.nagoya-u.ac.jp
Department of Nephrology,
Nagoya University Graduate School of Medicine
Department of Nephrology,
Nagoya University Graduate School of Medicine
Japan
NO
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)
2012 | Year | 05 | Month | 23 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/25795029
Completed
2012 | Year | 05 | Month | 17 | Day |
2012 | Year | 05 | Month | 01 | Day |
2014 | Year | 01 | Month | 01 | Day |
2014 | Year | 01 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2012 | Year | 05 | Month | 23 | Day |
2015 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009432
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