Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients
NCT ID: NCT01302236
Last Updated: 2012-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2011-03-31
2012-07-31
Brief Summary
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Detailed Description
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The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS and may induce aldosterone breakthrough that plays important roles for the development of CVD. Eplerenone, a selective aldosterone blocker, is effective against essential hypertension; however, little is known about the effects of eplerenone on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of eplerenone on heart and kidney functions in elderly hypertensive early stage (stage1 (eGFR\>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2)) CKD patients.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eplerenone
Eplerenone
50mg/day for all as initial dose, 100mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
Interventions
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Eplerenone
50mg/day for all as initial dose, 100mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Hypertension (Blood pressure \>=140/90mmHg)
* Elderly people(\>=65 years old)
Exclusion Criteria
* Stage3(eGFR 30-60 ml/min/1.73m2),stage4(eGFR 15-30 ml/min/1.73m2)and stage5 (eGFR \<15 ml/min/1.73m2) CKD patients
* The patients who are receiving hemodialysis or peritoneal dialysis
* The patients who are taking itraconazole, ritonavir and nelfinavir
* The patients who are taking potassium-sparing diuretics and potassium supplement
* The patients who have hyperkalemia(\>=5.5mEq/ml)
* Severe heart failure (\>=NYHA class III)
* Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (\>=HbA1c 9.0\&)
* Severe liver dysfunction (five folds increased AST or ALT than standard values)
65 Years
ALL
No
Sponsors
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Jichi Medical University
OTHER
Responsible Party
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Yoshiyuki Morishita
MD. PhD
Principal Investigators
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Yoshiyuki Morishita, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Nephrology, Department of Medicine, Jichi Medical University
Countries
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References
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Morishita Y, Hanawa S, Chinda J, Iimura O, Tsunematsu S, Kusano E. Effects of aliskiren on blood pressure and the predictive biomarkers for cardiovascular disease in hemodialysis-dependent chronic kidney disease patients with hypertension. Hypertens Res. 2011 Mar;34(3):308-13. doi: 10.1038/hr.2010.238. Epub 2010 Dec 2.
Other Identifiers
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JMU-N2
Identifier Type: -
Identifier Source: org_study_id