UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008615
Receipt number R000010126
Scientific Title A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).
Date of disclosure of the study information 2012/08/04
Last modified on 2016/02/04 15:03:54

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Basic information

Public title

A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).

Acronym

A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).

Scientific Title

A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).

Scientific Title:Acronym

A prospective comparison of direct renin inhibitor aliskiren and AT1 receptor blocker in hypertensive patients with chronic kidney disease(CKD).

Region

Japan


Condition

Condition

Hypertension
Chronic kidney disease

Classification by specialty

Medicine in general Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study compares effects of direct renin inhibitor aliskiren and AT1 receptor blocker (ARB) on blood pressure lowering, renal protection, ROS reduction and safety aspects in hypertensive patients with chronic kidney disease who are already treated with standard dose of ARB.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. BW, obesity, abdominal circumference
2. Clinical blood pressure
3. Home blood pressure
4. ABPM
5. Renal function (urinary protein/albumin/Cr excretion, BUN, eGFR, uric acid, L-FABP)
6. Vascular function(AI, ABI/baPWV), CAVI, FMD)
7. Sympathetic nerve activity
8. Glucose metabolism (FBS, HbA1C, IRI, HOMA-IR)
9. Lipid metabolism (TCHO, LDLC, HDLC, TG)
10.Endocrine (PRA, PAC, urinary aldosteron concentration, BNP)
11.Oxidative stress (h-s CRP, serum pentosidine)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Direct renin inhibitor group: Patients are initially given 150-300 mg of aliskiren once daily for 24 weeks.

Interventions/Control_2

ARB group: Patients are initially given standard dose of ARB once daily for 24 weeks.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Hypertensive patients with CKD G1-G4.
2. Patients who are already receiving antihypertensive therapy including ARB.

Key exclusion criteria

1. CKD G5, or dialysis patients.
2. History of hypersensitivity to ARB and/or aliskiren.
3. Pregnant women and/or women who are suspect of pregnancy.
4. Patients taking cyclosporin and/or itraconazole.
Patients with history of angioedema
5. Patients judged as inappropriate for the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichi TAMURA

Organization

Yokohama City University School of Medicine

Division name

Department of Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

Email

tamukou@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kouichi TAMURA

Organization

Yokohama City University School of Medicine

Division name

Department of Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

Homepage URL


Email

tamukou@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 04 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2015 Year 08 Month 31 Day

Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete


Date analysis concluded

2015 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 08 Month 04 Day

Last modified on

2016 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010126


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name