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

September 19, 2012 updated by: Yoshiyuki Morishita, Jichi Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Okayama
      • Niimi, Okayama, Japan, 719-2643
        • Niimi city Yukawa National health insurance clinic
    • Tochigi
      • Oyama, Tochigi, Japan, 329-0214
        • Konan Hospital
      • Sakura, Tochigi, Japan, 329-1395
        • Kurosu Hospital
      • Shimotsuke, Tochigi, Japan, 3290498
        • Jichi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aliskiren
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
Other Names:
  • Direct renin inhibitor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jichi Medical University

Investigators

  • Principal Investigator: Yoshiyuki Morishita, MD, PhD, Division of Nephrology, Department of Medicine, Jichi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimate)

January 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

September 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMU-N1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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