UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004062
Receipt number R000004458
Scientific Title Effects of Different Losartan Combination Antihypertensive Therapy in CKD Patients
Date of disclosure of the study information 2010/08/18
Last modified on 2014/08/19 21:55:05

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Basic information

Public title

Effects of Different Losartan Combination Antihypertensive Therapy in CKD Patients

Acronym

MIDLAND-CKD Study

Scientific Title

Effects of Different Losartan Combination Antihypertensive Therapy in CKD Patients

Scientific Title:Acronym

MIDLAND-CKD Study

Region

Japan


Condition

Condition

Chronic kidney disease patients complicated with hypertension

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparative effects of amlodipine with losartan versus low-dose hydrochlorothiazide with losartan on albuminuria in chronic kidney disease patients with hypertension

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Urinary albumin excretion from 0 to 3 months between 2 groups

Key secondary outcomes

A. Following parameters from 0 to 3 months between 2 groups;
1. Systolic and diastolic blood pressure
2. BNP
3. HOMA-beta and HOMA-IR
4. hs-CRP
5. eGFR
6. Urinnary sodium excretion
7. Serum K
8. HbA1c
9. Serum uric acid
10.Pulse wave velocity(PWV):optional
B. Following parameters from 0 to 6 months between 2 groups;
1. Urinary albumin excretionin
2. Serum K
3. HbA1c
4. Serum urin acid






Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

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

Administration of losartan 50mg and hydrochlorothiazide 12.5mg by a combination drug

Interventions/Control_2

Administration of losartan 50mg and amlodipine 2.5-5mg

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

1.Patients treated with losartan 50-100mg two months or more at the informed consent acquisition, and systolic blood pressure over 140, or diastolic blood pressure over 90 mmHg
2.Patients whose urinary protein in dipstic test was plus minus or greater in 2 times or more within 1 year before the informed consent acquisition
3.Outpatients
4.Sex unquestioned
5.20 and over,less than 80 years old








Key exclusion criteria

1. Patients whose serum creatinine was 2 mg/dL or greater within three months or patients whose eGFR were less than 30 mL/min/1.73 m2 before the informed consent acquisition
2. Patients whose hepatic function was over 3 times higher than normal upper limit within three months before the informed consent acquisition
3. Patients whose HbA1c was more than 8.0 within three months before the informed consent acquisition
4. Patients received hospitalizing by onset of cardiovascular disease, myocardial infarction, cerebral apoplexy, cardiac insufficiency within six months before the informed consent acquisition
5. Patients complicated angina pectoris, cardiac insufficiency with NYHA 3 or greater at the informed consent acquisition
6. Patients who is already prescribed diuretic or Ca antagonist at the informed consent acquisition
7. Patients with poor feeding
8. Patients of remarkable emaciation
9. Patients complicated with nephrotic syndrome
10. Patients judged unsuitable by physician in charge














Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoichi Maruyama

Organization

Nagoya University, Graduate School of Medicine

Division name

Department of Nephrology

Zip code


Address

65, Turumai-cho, Showa-ku, Nagoya, Aichi 466-8550

TEL

052-741-2111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshinari Yasuda

Organization

Nagoya University, Graduate School of Medicine

Division name

Department of Nephrology

Zip code


Address

65, Turumai-cho, Showaku, Nagoya, Aichi 466-8550

TEL

052-741-2111

Homepage URL


Email

yyasuda@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University CKD Clinical Cooperation System Study Group

Institute

Department

Personal name



Funding Source

Organization

Research Foundation for Community Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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

名古屋大学医学部附属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

No longer recruiting

Date of protocol fixation

2010 Year 02 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 08 Month 18 Day

Last modified on

2014 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004458


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name