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

Phase 4

Withdrawn

• Conditions: Hypertension; Chronic Kidney Disease.
• Interventions: Drug: Eplerenone

• Registration Number: NCT01302236
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Study Start: 2011-03
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-04
• Last Update Posted: 2012-07-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eplerenone	Eplerenone	-

Primary Outcome Measures

Name	Time	Method
The change of heart function confirmed by echocardiograph and plasma level of BNP	6 months
The change of renal function confirmed by eGFR and proteinuria.	6 months

Secondary Outcome Measures

Name	Time	Method
The change of blood pressure	6 months	The change of systolic blood pressure and diastolic blood pressure
The change of oxidative stress markers confirmed by plasma level of 8-OHdG and d-ROM	6 months