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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002448
Receipt No. R000002995
Scientific Title New"Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease" trial
Date of disclosure of the study information 2009/09/07
Last modified on 2009/09/04

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Basic information
Public title New"Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease" trial
Acronym New "COOPERATE" trial
Scientific Title New"Combination treatment of angiotensin-II receptor blocker and angiotensin-converting-enzyme inhibitor in non-diabetic renal disease" trial
Scientific Title:Acronym New "COOPERATE" trial
Region
Japan

Condition
Condition non-diabetic renal diseases
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate reno-protective effects of combination treatment of ACE-I and ARB.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes time to doubling of serum creatinine concentration or ESRD
Key secondary outcomes blood pressure, proteinuria

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 YES
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ACE-I alone
Interventions/Control_2 ARB alone
Interventions/Control_3 Combination of ACE-I and ARB
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
17 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)non-diabetic CKD patients with a written informed consent
Key exclusion criteria 1)hemodialysis or peritoneal dialysis patients
2)patients with remarkable edema
3)patients who need therapy with steroid and/or immunosuppresants
4)alcohol abuse
6)expecting mothers
7)those allergic to ACE-I or ARB
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ashio Yoshimura
Organization Showa University Fujigaoka Hospital
Division name Division of Nephrology, Department of Medicine
Zip code
Address 1-30 Fujigaoka, Aoba-ku, Yokohama-city, Kanagawa 227-8501, Japan
TEL +81-45-971-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Morita
Organization Showa University Fujigaoka Hospital
Division name Division of Nephrology, Department of Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 07 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 Open public recruiting
Date of protocol fixation
2009 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 04 Day
Last modified on
2009 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002995

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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