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Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01302236
Recruitment Status : Withdrawn (We could not find patients who agreed to enrolled this clinical study.)
First Posted : February 24, 2011
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):
Yoshiyuki Morishita, Jichi Medical University

Brief Summary:
The purpose of this study is to determine whether eplerenone is effective in the treatment of blood pressure, heart function, renal function in elderly hypertensive stage1 (eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2) chronic kidney disease (CKD) patients.

Condition or disease Intervention/treatment Phase
Hypertension Chronic Kidney Disease. Drug: Eplerenone Phase 4

Detailed Description:

Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called "Cardio-renal Continuum". The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Eplerenone on Blood Pressure, Heart and Kidney in Elderly Hypertensive Early Stage Chronic Kidney Disease Patients
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Eplerenone Drug: 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 Name: Selective aldosterone blocker

Primary Outcome Measures :
  1. The change of heart function confirmed by echocardiograph and plasma level of BNP [ Time Frame: 6 months ]
  2. The change of renal function confirmed by eGFR and proteinuria. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The change of blood pressure [ Time Frame: 6 months ]
    The change of systolic blood pressure and diastolic blood pressure

  2. The change of oxidative stress markers confirmed by plasma level of 8-OHdG and d-ROM [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of stage1(eGFR>=90ml/min/1.73m2) and stage2 (eGFR 60- 89ml/min/1.73m2)chronic kidney disease
  • Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
  • Elderly people(>=65 years old)

Exclusion Criteria:

  • The patients who are already taking eplerenone
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01302236

Sponsors and Collaborators
Jichi Medical University
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Principal Investigator: Yoshiyuki Morishita, MD. PhD Division of Nephrology, Department of Medicine, Jichi Medical University
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Responsible Party: Yoshiyuki Morishita, MD. PhD, Jichi Medical University Identifier: NCT01302236    
Other Study ID Numbers: JMU-N2
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012
Keywords provided by Yoshiyuki Morishita, Jichi Medical University:
Early stage chronic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents