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

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Sponsor:
Information provided by (Responsible Party):
Yoshiyuki Morishita, Jichi Medical University
ClinicalTrials.gov Identifier:
NCT01302236
First received: February 23, 2011
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Hypertension
Chronic Kidney Disease.
Drug: Eplerenone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jichi Medical University:

Primary Outcome Measures:
  • The change of heart function confirmed by echocardiograph and plasma level of BNP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • The change of renal function confirmed by eGFR and proteinuria. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change of blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302236

Sponsors and Collaborators
Jichi Medical University
Investigators
Principal Investigator: Yoshiyuki Morishita, MD. PhD Division of Nephrology, Department of Medicine, Jichi Medical University
  More Information

Publications:
Responsible Party: Yoshiyuki Morishita, MD. PhD, Jichi Medical University
ClinicalTrials.gov Identifier: NCT01302236     History of Changes
Other Study ID Numbers: JMU-N2
Study First Received: February 23, 2011
Last Updated: July 4, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Jichi Medical University:
Elderly
Early stage chronic kidney disease
Hypertension
Eplerenone

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014