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

Effects of Eplerenone on Blood Pressure, Heart and Kidney in Elderly Hypertensive Early Stage Chronic Kidney Disease Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Chronic Kidney Disease.
• Intervention / Treatment: Drug: Eplerenone

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 Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Selective aldosterone blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
The change of blood pressure	The change of systolic blood pressure and diastolic blood pressure	6 months
The change of oxidative stress markers confirmed by plasma level of 8-OHdG and d-ROM		6 months

Collaborators and Investigators

• Sponsor: Jichi Medical University
• Investigators: Principal Investigator: Yoshiyuki Morishita, MD. PhD, Division of Nephrology, Department of Medicine, Jichi Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 4, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Elderly; Hypertension; Eplerenone; Early stage chronic kidney disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Renal Insufficiency; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Antihypertensive Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Eplerenone
• Other Study ID Numbers: JMU-N2