UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002448 |
|---|---|
| Receipt number | 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 20:12:55 |
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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
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
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002995
