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

Study Overview
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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.

Official Title
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Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients

Conditions
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Hypertension, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Aliskiren


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aliskiren<br> | Drug: Aliskiren<br>* 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<br>* Other names: Direct renin inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Blood Pressure | The change of systolic blood pressure and diastolic blood pressure | baseline and 6 month | 
| The Change of Heart Function Confirmed by Echocardiograph | Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month. Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month. | baseline and 6 month | 
| The Change of BNP | Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month. | baseline and 6month | 
| The Change of eGFR | eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73 m2) = 194 × age-0.287 × serum creatinine-1.094 (multiplied by 0.739 for females). | baseline and 6 month | 
| The Change of Urine Albumin/ Creatinine Ratio (UACR). | The UACR was measured at baseline, Week12 and Week24 | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Elderly chronic kidney disease, Aliskiren