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

NCT01302236 | Withdrawn Phase 4

• 1 other identifier: JMU-N2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Chronic Kidney Disease.

Keywords

Elderly; Early stage chronic kidney disease; Hypertension; Eplerenone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The change of blood pressure

  6 months

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

  6 months

Study Arms (1)

Eplerenone

EXPERIMENTAL

Drug: Eplerenone

Interventions

Eplerenone DRUG

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

Eplerenone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jichi Medical University: lead

Related Publications (1)

• 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.

  PMID: 21124333 BACKGROUND

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yoshiyuki Morishita, MD. PhD

  Division of Nephrology, Department of Medicine, Jichi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 6, 2012

Record last verified: 2012-07