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Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients

NCT ID: NCT01284114

Last Updated: 2012-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.

Detailed Description

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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, leading to a reactive rise in plasma renin activity (PRA). Aliskiren, an oral direct renin inhibitor, is effective against essential hypertension by reducing PRA, resulting in more complete suppression of RAS; however, little is known about the effects of aliskiren on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of aliskiren on heart and kidney functions in elderly hypertensive CKD patients.

Conditions

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Hypertension Chronic Kidney Disease

Keywords

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Elderly chronic kidney disease Hypertension Aliskiren

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aliskiren

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months

Interventions

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Aliskiren

150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months

Intervention Type DRUG

Other Intervention Names

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Direct renin inhibitor

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Chronic kidney disease
* Clinical diagnosis of Hypertension (Blood pressure \>=140/90mmHg)
* Elderly people(\>=65 years old)

Exclusion Criteria

* The patients who are already taking aliskiren
* The patients who are receiving hemodialysis or peritoneal dialysis
* The patients who are taking cyclosporin
* 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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jichi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yoshiyuki Morishita

MD. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoshiyuki Morishita, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Department of Medicine, Jichi Medical University

Locations

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Niimi city Yukawa National health insurance clinic

Niimi, Okayama-ken, Japan

Site Status

Konan Hospital

Oyama, Tochigi, Japan

Site Status

Kurosu Hospital

Sakura, Tochigi, Japan

Site Status

Jichi Medical University

Shimotsuke, Tochigi, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 21124333 (View on PubMed)

Other Identifiers

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JMU-N1

Identifier Type: -

Identifier Source: org_study_id