UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001803
Receipt number R000002148
Scientific Title Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial
Date of disclosure of the study information 2009/03/27
Last modified on 2015/07/16 20:32:05

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Basic information

Public title

Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial

Acronym

Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial (EVALUATE)

Scientific Title

Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial

Scientific Title:Acronym

Eplerenone Combination Versus Conventional Agents to Lower Blood Pressure on Urinary Antialbuminuric Treatment Effect Trial (EVALUATE)

Region

Japan


Condition

Condition

Hypertensive patients with albuminuria under the treatment of the inhibitor of the renin-angiotension system (RAS)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the antialbuminuric effect of eplerenone (50 mg/day) by comparing the effects between eplerenone and placebo on change in urinary albumin/creatinine (Cr) ratio

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Percent changes in urinary albumin/Cr ratio in first morning void urine from pretreatment period (average of 3 continuously-measured values) to 12 months of treatment

Key secondary outcomes

1. Urinary albumin/Cr ratio in first morning void urine: Absolute value, percent changes from pretreatment period to each period of treatment, etc.
2. Urinary liver-type free fatty acid-binding protein (L-FABP)
3. Office blood pressure (BP)
4. Serum Cr or estimated glomerular filtration rate (eGFR) calculated using the modified MDRD formula in the Japanese Society of Nephrology: eGFR (ml/min/1.73 m2) = 194 x age -0.287 x serum Cr - 1.094 (multiply by 0.739 in female)
5. Estimated urinary sodium (Na) excretion for a day: Estimated urinary Na excretion for 24 hours (mmol/day) =21.98x{[urinary Na (mEq/L) / urinary Cr (mg/L)] x [-2.04 x age + 14.89 x body weight (kg) +16.14 x height (cm) - 2244.45]}0.392
6. Cerebro-cardio-vascular events: cerebro-cardio-vascular death (fatal myocardial infarction, fatal heart failure, sudden death, fatal stroke, other cardiovascular death) and hospitalization due to cerebro-cardio-vascular disease (nonfatal myocardial infarction, angina, heart failure, cerebral bleeding, cerebral infarction, transient cerebral ischemic attack)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Placebo is added in patients under the treatment of the RAS inhibitor.
If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS is added.

Interventions/Control_2

Eplerenone (50mg/day) is added in patients with the treatment of the RAS inhibitor.
If BP does not reach to lower than 130/80 mmHg, other antihypertensive drug than aldosterone antagonist and inhibitor of RAS 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients to fulfill all the following condition can participate
1. Outpatient systolic BP is equal or more than130 mmHg and less than 180 mmHg, and/or outpatient diastolic BP is equal or more than 80 mmHg and less than 110 mmHg
2. Urinary albumin/Cr ratio in first morning void urine at pretreatment period (average of 3 continuously-measured values) is equal or more than 30 mg/g and less than 600 mg/g
3. Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) has been administered for more than 8 weeks when the interim registration is done
4. eGFR is equal or more than 50 mL/min/1.73m2.
5. Age is equal or more than 20 and less than 80 year-old
6. Written informed consent is obtained based on written and oral explanation of physician in charge

Key exclusion criteria

1. Hypertensive emergency that requires intravenous administration of antihypertensives
2. Aldosterone antagonist has been administered within 8 weeks when the interim registration is done
3. Administration of adrenocorticosteroidal drug, immunosuppressant or long-term (equal or more than 2 weeks) administration of non-steroid anti-inflammatory drugs (NSAID)
4. Serum potassium (K) is equal or more than 5.0 mEq/L
5. Fasting blood glucose is equal or more than 126 mg/dL or anti-diabetic drug is administered.
6. Severe liver damage (Child-Pugh Score: class C)
7. Sever heart failure (NYHA class is equal or more than III), severe arrhythmia (frequent ventricular or atrial extrasystole, prolonged ventricular tachycardia, atrial tachyrhythmia with severe tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome with severe bradycardia, atrio-ventricular block with severe bradycardia), angina, or myocardial infarction within 6 months
8. Cerebrovascular disease occurs within 6 months
9. Pregnant, possible to be pregnant, or willing to be pregnant
10. Past history of severe side effect of aldosterone antagonist, ACE inhibitor or ARB
11. Supplementation of K or administration of K-sparing diuretics, itraconazole, ritonavir, or nelfinavir.
12. Patients who are inadequate by determination of physician in charge

Target sample size

340


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiro Fujita

Organization

University of Tokyo Graduate School of Medicine

Division name

Department of Nephrology and Endocrinology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan

TEL

03-5800-9735

Email

toshiro.fujita@rcast.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuyuki Ando

Organization

University of Tokyo Graduate School of Medicine

Division name

Department of Nephrology and Endocrinology

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8165, Japan

TEL

03-5800-9119

Homepage URL

https://center.umin.ac.jp/islet/evaluate/

Email

katsua-tky@umin.sc.jp


Sponsor or person

Institute

EVALUATE Project office

Institute

Department

Personal name



Funding Source

Organization

Pfizer Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2009 Year 03 Month 27 Day


Related information

URL releasing protocol

http://evaluate.umin.jp/

Publication of results

Published


Result

URL related to results and publications

http://www.u-tokyo.ac.jp/public/public01_261028_j.html

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

Main results already published

Date of protocol fixation

2008 Year 11 Month 20 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2013 Year 06 Month 30 Day

Date analysis concluded

2014 Year 08 Month 31 Day


Other

Other related information

http://www.thelancet.com/pdfs/journals/landia/PIIS2213-8587%2814%2970194-9.pdf


Management information

Registered date

2009 Year 03 Month 27 Day

Last modified on

2015 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002148


Research Plan
Registered date File name
2015/07/16 EVALUATE臨床試験計画書110509kuro血糖.doc

Research case data specifications
Registered date File name
2015/07/16 【確定】 解析時データ対応確認内容3_20130626.xls

Research case data
Registered date File name