UMIN-CTR Clinical Trial

Public title

Investigation of an efficacy of eplerenone combined therapy for hypertensive patients with chronic kidney disease that enough hypotensive effect are not obtained with an angiotensin receptor blocker

Acronym

Optimal Hypertension Therapy with Aldosterone Blocker Selara (OWASE)

Scientific Title

Investigation of an efficacy of eplerenone combined therapy for hypertensive patients with chronic kidney disease that enough hypotensive effect are not obtained with an angiotensin receptor blocker

Scientific Title:Acronym

Optimal Hypertension Therapy with Aldosterone Blocker Selara (OWASE)

Region

Japan

Condition

Hypertensive patients with chronic kidney disease that enough hypotensive effect is not obtained with an angiotensin receptor blocker

Classification by specialty

Medicine in general	Cardiology	Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the antialbuminuric effect of eplerenone by comparing the effects of thiazide diuretics on change in urinary albumin/creatinine ratio

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Changes in urinary albumin/creatinine ratio from pretreatment period to 12 months of treatment

Key secondary outcomes

1. Change in office blood pressure
2. Change in estimated glomerular filtration rate (eGFR)
3. Change in urinary protein
4. Change in brachial-ankle pulse wave velocity (baPWV)
5. Change in BNP
6. Change in cardiac ultrasonography findings (ejection fraction, E', A', E/E', left ventricukar mass)
7. Cerebro-cardio-vascular events (all death, non-fatal myocardial infarction, angina pectoris, stroke, heart failure)
8. Side effect of eplerenone or thiazide diuretics

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eplerenone (50mg/day) is added in patients under treatment of angiotensin receptor blocker (ARB). If blood pressure dose not reach to lower than 130/80mmHg, other antihypertensive drug except ARB, eplerenone and thiazide diuretics is added.

Interventions/Control_2

Thiazide diuretics (hydrochlorothiazide 12.5mg/day or trichlormetiazide 1mg/day) is added in patients under treatment of angiotensin receptor blocker (ARB). If blood pressure dose not reach to lower than 130/80mmHg, other antihypertensive drug except ARB, eplerenone and thiazide diuretics is added.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Among the following, the patient satisfying all the conditions from 1 to 4 becomes a subject.
1. Urinary albumin/creatinine ratio is more than 10mg/gCr
2. Though angiotensin receptor blocker has been administered for more than 3 months, systolic blood pressure is equal or more than 130mmHg or diastolic blood pressure is equal or more than 80mmHg (in patients developing that urinary protein is equal or more than 1g/day, systolic blood pressure 125mmHg or diastolic blood pressure is qual or more than 75mmHg)
3. Age is equal or more than 20
4. Patients who have given written informed consent to participate in this study

Key exclusion criteria

1. Uncontrolled hypertension (systolic blood pressure is equal or more 220 mmHg, or diastolic blood pressure is equal or more 110 mmHg)
2. Unstable angina pectoris
3. Myocardial infarction occurs within 6 months
4. Severe heart failure (NYHA class is equal or more than III)
5. Severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyarrhythmia, atrial fibrillation, atrial flutter, sick sinus syndrome or atrio-ventricular block)
6. eGFR is less than 36mL/min/1.73m2
7. Severe liver dysfunction or Child-Pugh class score is C
8. Active cancer
9. Serum potassium is equal or more than 5 mEq/L
10. Diabetic patients with microalbuminuria (urinary albumin/creatinine ratio is equal or more than 30mg/gCr) or proteinuria
11. Supplementation of K or administration of K-sparing diuretics
12. Administration of itraconazole, ritonavir or nelfinavir
13. Administration of steroid or immunosuppressant
14. Pregnant, possible to be pregnant
15. Patient who is already treated for study drugs
16. Patients with allergy or contraindication to study drugs
17. Patients that it is impossible to get an agreement
18. Patients who are inadequate by determination of physician in charge

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Masaaki Ito

Organization

Mie University Graduate School of Medicine

Division name

Department of Cardiology and Nephrology

Zip code

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-231-5015

Email

mitoka@clin.medic.mie-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Mashio Nakamura

Organization

Mie University Graduate School of Medicine

Division name

Department of Cardiology and Nephrology

Zip code

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-231-5015

Homepage URL

Email

mashio@clin.medic.mie-u.ac.jp

Institute

OWASE study Project Office

Institute

Department

Personal name

Organization

Department of Cardiology and Nephrology, Mie University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Pfizer Japan Inc.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学医学部附属病院
尾鷲総合病院
桑名東医療センター
四日市社会保険病院
三重県立総合医療センター
鈴鹿中央総合病院
松阪中央総合病院
済生会松阪総合病院
伊勢赤十字病院
村瀬病院
岩崎病院
名張市立病院

Date of disclosure of the study information

2011

Year

07

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

07

Month

10

Day

Last modified on

2016

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005773