HypertensionPhase 4NCT01284114

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

A Phase 4 study testing Aliskiren in people with Hypertension and Chronic Kidney Disease, run by Jichi Medical University at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Hypertension, Chronic Kidney Disease
What is being tested?: Aliskiren
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 4 sitesJapan
Study dates: Feb 2011to May 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Clinical diagnosis of Chronic kidney disease
Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
Elderly people(>=65 years old)

Who cannot join

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)

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

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

Other trials in Japan

About this study

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

Read the 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.

Conditions: Hypertension, Chronic Kidney Disease
Being tested: Aliskiren
Keywords: Elderly chronic kidney disease, Hypertension, Aliskiren
Medical subject headings: Hypertension, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AliskirenDrug
Also called Direct renin inhibitor
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

Study groups in NCT01284114
Study group	Role	What they receive
Aliskiren	Active comparator	Not described Receives: Drug: Aliskiren

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011May 2012

First posted26 Jan 2011 (estimated)
Study startFeb 2011
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01284114
Sponsor's protocol ID: JMU-N1
Status last verified: Jul 2012
First submitted: 25 Jan 2011
Last updated: 22 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21124333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients
ClinicalTrials.gov ID: NCT01284114
Acronym / sponsor ID: JMU-N1
Conditions: Hypertension, Chronic Kidney Disease
Keywords: Elderly chronic kidney disease, Hypertension, Aliskiren
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Jichi Medical UniversityUniversity, hospital or other
Study start: Feb 2011
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 26 Jan 2011 (estimated)
Results: Posted 22 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aliskiren	Active comparator	Drug: Aliskiren

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Clinical diagnosis of Chronic kidney disease
Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
Elderly people(>=65 years old)

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AliskirenAlso: Direct renin inhibitor150mg/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	Drug	Aliskiren

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 22 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aliskiren	23	19

Primary outcome: The Change of Blood Pressure

Time frame: baseline and 6 month. Mean (Standard Deviation). Unit: mmHg

Measure	Aliskiren n = 19
systolic blood pressure	-22.7 (0.7)
diastolic blood pressure	-5 (-0.5)

Population analysed: We analyzed all patients who completed study.

Primary outcome: The Change of Heart Function Confirmed by Echocardiograph

Time frame: baseline and 6 month. Mean (Standard Deviation). Unit: % of stroke vulume/enddiastolic volume

Measure	Aliskiren n = 19
Value	-0.3 (-1.1)

Population analysed: We analyzed participants who copmleted this study

Primary outcome: The Change of BNP

Time frame: baseline and 6month. Mean (Standard Deviation). Unit: pg/ml

Measure	Aliskiren n = 19
Value	6.7 (-4.9)

Population analysed: We analyzed all patients who completed study.

Primary outcome: The Change of eGFR

Time frame: baseline and 6 month. Mean (Standard Deviation). Unit: mL/min/1.73m2

Measure	Aliskiren n = 19
Value	-0.9 (-0.1)

Population analysed: We analyzed all patients who completed study.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 4.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aliskiren	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21124333Morishita 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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoshiyuki Morishita, MD, PhD principal investigator

Division of Nephrology, Department of Medicine, Jichi Medical University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aliskiren in people with Hypertension and Chronic Kidney Disease, run by Jichi Medical University at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change of Blood Pressure (time frame: baseline and 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284114, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2012.