Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients|
- The Change of Blood Pressure [ Time Frame: baseline and 6 month ] [ Designated as safety issue: Yes ]The change of systolic blood pressure and diastolic blood pressure
- The Change of Heart Function Confirmed by Echocardiograph [ Time Frame: baseline and 6 month ] [ Designated as safety issue: Yes ]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 [ Time Frame: baseline and 6month ] [ Designated as safety issue: Yes ]Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
- The Change of eGFR [ Time Frame: baseline and 6 month ] [ Designated as safety issue: Yes ]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). [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]The UACR was measured at baseline, Week12 and Week24
- The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 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
Other Name: Direct renin inhibitor
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284114
|Niimi city Yukawa National health insurance clinic|
|Niimi, Okayama, Japan, 719-2643|
|Oyama, Tochigi, Japan, 329-0214|
|Sakura, Tochigi, Japan, 329-1395|
|Jichi Medical University|
|Shimotsuke, Tochigi, Japan, 3290498|
|Principal Investigator:||Yoshiyuki Morishita, MD, PhD||Division of Nephrology, Department of Medicine, Jichi Medical University|