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

Phase 4

Completed

• Conditions: Hypertension; Chronic Kidney Disease
• Interventions: Drug: Aliskiren

• Registration Number: NCT01284114
• Lead Sponsor: Jichi Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Study Start: 2011-02
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Results First Submitted: 2012-07-05
• Results First Submitted QC: 2012-09-19
• Last Update Submitted: 2012-09-19
• Results First Posted: 2012-10-22
• Last Update Posted: 2012-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aliskiren	Aliskiren	-

Primary Outcome Measures

Name	Time	Method
The Change of Blood Pressure	baseline and 6 month	The change of systolic blood pressure and diastolic blood pressure
The Change of Heart Function Confirmed by Echocardiograph	baseline and 6 month	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.
The Change of BNP	baseline and 6month	Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
The Change of eGFR	baseline and 6 month	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).
The Change of Urine Albumin/ Creatinine Ratio (UACR).	baseline and 6 months	The UACR was measured at baseline, Week12 and Week24

Secondary Outcome Measures

Name	Time	Method
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM	6 months

Trial Locations

Locations (4)

Kurosu Hospital; 🇯🇵 Sakura, Tochigi, Japan

Niimi city Yukawa National health insurance clinic; 🇯🇵 Niimi, Okayama, Japan

Konan Hospital; 🇯🇵 Oyama, Tochigi, Japan

Jichi Medical University; 🇯🇵 Shimotsuke, Tochigi, Japan