Unique ID issued by UMIN | UMIN000022999 |
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Receipt number | 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 | 2023/05/09 18:32:16 |
anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
anti-albuminuric effect of 1ow-dose spironolactone in patients with diabetic nephropathy
Japan |
diabetic nephropathy
Endocrinology and Metabolism | Nephrology |
Others
NO
we aim to prove the anti-albuminuric effect and safety of spironolactone 12.5mg once daily compared with controls in patients with diabetic nephropathy
Safety,Efficacy
reduction in the rate of albuminuria at 24 weeks after administration.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
spironolactone 12.5mg once a day for 24 weeks.
control
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
130
1st name | Ako |
Middle name | |
Last name | Oiwa |
Shinshu University Hospital
Diabetes, Endocrinology and Metabolism
390-8621
3-1-1 Asahi, Matumoto-shi, Nagano, JAPAN
0263-37-2686
akooiwa@shinshu-u.ac.jp
1st name | Ako |
Middle name | |
Last name | Oiwa |
Shinshu University Hospital
Diabetes, Endocrinology and Metabolism
390-8621
3-1-1 Asahi, Matumoto-shi, Nagano, JAPAN
0263-37-2686
akooiwa@shinshu-u.ac.jp
Diabetes, Endocrinology and Metabolism,
Shinshu University Hospital
Diabetes, Endocrinology and Metabolism,
Shinshu University Hospital
Self funding
Takeda Clinic of Internal Medicine
Miyamoto Clinic of Internal Medicine
Ethics Committee Secretariat, Shinshu University Hospital
3-1-1 Asahi Matsumoto, Nagano-ken, Japan
+81-263-37-2572
mdrinri@shinshu-u.ac.jp
NO
2016 | Year | 07 | Month | 03 | Day |
https://shinshu.bvits.com/rinri/Apply/show.aspx?TYPE=1&ID=7926
Published
https://doi.org/10.1210/clinem/dgad144
130
The spironolactone group showed a significant reduction in UACR from baseline compared with the control group which showed an increased UACR (p = 0.0007, Wilcoxon rank-sum test and t-test). Although the spironolactone group had a statistically significant increase in serum potassium levels, none of the participants had a potassium level >5.5 mEq/L at 24 weeks. Further, participants with a higher initial serum potassium level tended to have a smaller increase (estimate -0.37, analysis of covariance).
2023 | Year | 05 | Month | 09 | Day |
We enrolled 130 Japanese adults with type 2 diabetes and albuminuria (>30 mg/gCre) from July 2016 to December 2018 (84 from Shinshu University Medical Hospital, 31 from Takeda Internal Medicine Clinic, and 15 from Miyamoto Internal Medicine Clinic). The inclusion criteria were as follows: 1) aged >20 years, 2) estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 calculated using serum creatinine level, and 3) taking RAS blockers for over 180 days. The exclusion criteria were as follows: 1) serum potassium level > 5.0 mEq/L, 2) already taking MRAs, 3) history of adverse events caused by MRAs, and 4) pregnancy or breastfeeding.
In total, 130 patients were randomly assigned to two groups, with one receiving additive treatment with spironolactone (12.5 mg/day) and the other receiving medication therapy without spironolactone. Stratified randomization was performed at the Center for Clinical Research of Shinshu University Hospital. The stratifying factors for randomization were duration of diabetes (>10 years or <10 years), eGFR (>60 mL/min/1.73 m2 or <60 mL/min/1.73 m2), and urine albumin-to-creatinine ratio (UACR) (30 to 300 mg/gCre or >300 mg/gCre).
Follow-up visits were conducted at 12 weeks and 24 weeks of observational periods and 12 weeks after the end of the study. Blood pressure and body weight measurements, physical examinations, and interviews regarding adverse events were conducted at these visits. At each visit, we interviewed the participants about their urine color, food intake, whether they exercised hard, felt tired, had a cold, and were in their period because these factors could cause an increase in urinary albumin excretion. The primary and secondary endpoint data were obtained at the start of the study, 12-week, and 24-week observational periods. Urine and blood samples were collected at all times in the outpatient department. The criteria for decision-making if patients should discontinue the study were as follows: 1) eGFR <30 mL/min/1.73 m2, 2) serum potassium level >5.5 mEq/L, 3) systolic pressure <100 mmHg; and 4) gynecomastia with the wish of patients themselves to resign from the study.
One of the participants withdrew from the study because he became aware of gynecomastia. No other adverse events were observed.
The primary outcome measure was the change in UACR from baseline to the 24-week intervention period. The secondary outcome measurements were the changes from baseline to the 24-week in serum potassium, serum creatinine, eGFR, cystatin C, uric acid, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride, aldosterone, blood pressure, and body weight in the same intervention period.
Completed
2016 | Year | 06 | Month | 07 | Day |
2016 | Year | 03 | Month | 14 | Day |
2016 | Year | 07 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2016 | Year | 07 | Month | 03 | Day |
2023 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026509
Research Plan | |
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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 |
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