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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284114
• Other study ID #: JMU-N1
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2011
• Last updated: September 19, 2012
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Jichi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	Niimi city Yukawa National health insurance clinic	Niimi	Okayama
Japan	Konan Hospital	Oyama	Tochigi
Japan	Kurosu Hospital	Sakura	Tochigi
Japan	Jichi Medical University	Shimotsuke	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Jichi Medical University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change of Blood Pressure	The change of systolic blood pressure and diastolic blood pressure	baseline and 6 month	Yes
Primary	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	Yes
Primary	The Change of BNP	Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.	baseline and 6month	Yes
Primary	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	Yes
Primary	The Change of Urine Albumin/ Creatinine Ratio (UACR).	The UACR was measured at baseline, Week12 and Week24	baseline and 6 months	Yes
Secondary	The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM		6 months	No