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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004062
Receipt No. 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

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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
Institute Nagoya University CKD Clinical Cooperation System Study Group
Institute
Department

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
URL(English) https://upload.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


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