Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
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|ClinicalTrials.gov Identifier: NCT01284114|
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : October 22, 2012
Last Update Posted : October 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Chronic Kidney Disease||Drug: Aliskiren||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients|
|Study Start Date :||February 2011|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
|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
- The Change of Blood Pressure [ Time Frame: baseline and 6 month ]The change of systolic blood pressure and diastolic blood pressure
- The Change of Heart Function Confirmed by Echocardiograph [ Time Frame: 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 [ Time Frame: baseline and 6month ]Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
- The Change of eGFR [ Time Frame: 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). [ Time Frame: baseline and 6 months ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|