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WithdrawnNCT01302236Updated Jul 6, 2012

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

A Phase 4 interventional study of Eplerenone in Hypertension and Chronic Kidney Disease., sponsored by Jichi Medical University. Withdrawn. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2012-07-06.

Sponsored by Jichi Medical University · Phase 4, Interventional, and Treatment

Why this study was withdrawn
We could not find patients who agreed to enrolled this clinical study.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
65 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hypertension
  • Chronic Kidney Disease.

Keywords

  • Elderly
  • Early stage chronic kidney disease
  • Hypertension
  • Eplerenone
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

Jichi Medical University is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Eplerenone

    Drug: Eplerenone

Interventions

  • DrugEplerenone

    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

    Also known as: Selective aldosterone blocker

06

What researchers measure

Primary outcomes

  1. The change of heart function confirmed by echocardiograph and plasma level of BNP

    Time frame: 6 months

  2. The change of renal function confirmed by eGFR and proteinuria.

    Time frame: 6 months

Secondary outcomes

  1. The change of blood pressure

    The change of systolic blood pressure and diastolic blood pressure

    Time frame: 6 months

  2. The change of oxidative stress markers confirmed by plasma level of 8-OHdG and d-ROM

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 21124333 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01302236
Lead sponsor
Jichi Medical University
Responsible party
Yoshiyuki Morishita (MD. PhD, Jichi Medical University) — Principal investigator
First posted
Feb 24, 2011
Start date
Mar 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Jul 6, 2012

Study contacts

Yoshiyuki Morishita, MD. PhD
principal investigator · Division of Nephrology, Department of Medicine, Jichi Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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