Clinical trial NCT01284114: Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
Official title: Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Chronic Kidney Disease
Keywords: Elderly chronic kidney disease
Hypertension
Aliskiren
Lead sponsor: Jichi Medical University
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Change of Blood Pressure
timeFrame: baseline and 6 month
measure: The Change of Heart Function Confirmed by Echocardiograph
timeFrame: baseline and 6 month
measure: The Change of BNP
timeFrame: baseline and 6month
measure: The Change of eGFR
timeFrame: baseline and 6 month
measure: The Change of Urine Albumin/ Creatinine Ratio (UACR).
timeFrame: baseline and 6 months
Secondary outcomes:
measure: The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
timeFrame: 6 months
Other outcomes:
Locations:
city: Niimi
country: Japan
facility: Niimi city Yukawa National health insurance clinic
state: Okayama
city: Oyama
country: Japan
facility: Konan Hospital
state: Tochigi
city: Sakura
country: Japan
facility: Kurosu Hospital
state: Tochigi
city: Shimotsuke
country: Japan
facility: Jichi Medical University
state: Tochigi
Study officials:
affiliation: Division of Nephrology, Department of Medicine, Jichi Medical University
name: Yoshiyuki Morishita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.