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

Primary Purpose

Hypertension, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aliskiren
Sponsored by
Jichi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Elderly chronic kidney disease, Hypertension, Aliskiren

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Niimi city Yukawa National health insurance clinic
  • Konan Hospital
  • Kurosu Hospital
  • Jichi Medical University

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Aliskiren

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM

Full Information

First Posted
January 25, 2011
Last Updated
September 19, 2012
Sponsor
Jichi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01284114
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jichi Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Kidney Disease
Keywords
Elderly chronic kidney disease, Hypertension, Aliskiren

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Direct renin inhibitor
Intervention Description
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
Primary Outcome Measure Information:
Title
The Change of Blood Pressure
Description
The change of systolic blood pressure and diastolic blood pressure
Time Frame
baseline and 6 month
Title
The Change of Heart Function Confirmed by Echocardiograph
Description
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.
Time Frame
baseline and 6 month
Title
The Change of BNP
Description
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
Time Frame
baseline and 6month
Title
The Change of eGFR
Description
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).
Time Frame
baseline and 6 month
Title
The Change of Urine Albumin/ Creatinine Ratio (UACR).
Description
The UACR was measured at baseline, Week12 and Week24
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiyuki Morishita, MD, PhD
Organizational Affiliation
Division of Nephrology, Department of Medicine, Jichi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Niimi city Yukawa National health insurance clinic
City
Niimi
State/Province
Okayama
ZIP/Postal Code
719-2643
Country
Japan
Facility Name
Konan Hospital
City
Oyama
State/Province
Tochigi
ZIP/Postal Code
329-0214
Country
Japan
Facility Name
Kurosu Hospital
City
Sakura
State/Province
Tochigi
ZIP/Postal Code
329-1395
Country
Japan
Facility Name
Jichi Medical University
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21124333
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.
Results Reference
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Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients

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