Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients
Primary Purpose
Hypertension, Chronic Kidney Disease.
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Elderly, Early stage chronic kidney disease, Hypertension, Eplerenone
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eplerenone
Arm Description
Outcomes
Primary Outcome Measures
The change of heart function confirmed by echocardiograph and plasma level of BNP
The change of renal function confirmed by eGFR and proteinuria.
Secondary Outcome Measures
The change of blood pressure
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
Full Information
NCT ID
NCT01302236
First Posted
February 23, 2011
Last Updated
July 4, 2012
Sponsor
Jichi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01302236
Brief Title
Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients
Official Title
Effects of Eplerenone on Blood Pressure, Heart and Kidney in Elderly Hypertensive Early Stage Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
We could not find patients who agreed to enrolled this clinical study.
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jichi Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Kidney Disease.
Keywords
Elderly, Early stage chronic kidney disease, Hypertension, Eplerenone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eplerenone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Selective aldosterone blocker
Intervention Description
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
Primary Outcome Measure Information:
Title
The change of heart function confirmed by echocardiograph and plasma level of BNP
Time Frame
6 months
Title
The change of renal function confirmed by eGFR and proteinuria.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The change of blood pressure
Description
The change of systolic blood pressure and diastolic blood pressure
Time Frame
6 months
Title
The change of oxidative stress markers confirmed by plasma level of 8-OHdG and d-ROM
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiyuki Morishita, MD. PhD
Organizational Affiliation
Division of Nephrology, Department of Medicine, Jichi Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21124333
Citation
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.
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Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients
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