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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Withdrawn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
Jichi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Elderly, Early stage chronic kidney disease, Hypertension, Eplerenone

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 23, 2011
    Last Updated
    July 4, 2012
    Sponsor
    Jichi Medical University
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    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.
    Results Reference
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    Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients

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