UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003817 |
|---|---|
| Receipt number | R000004602 |
| Scientific Title | The comparative study between direct renin inhibitor and angiotensin II receptor antagonist in hypertensive patients with chronic kidney disease |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2012/07/18 14:27:32 |
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Basic information
Public title
The comparative study between direct renin inhibitor and angiotensin II receptor antagonist in hypertensive patients with chronic kidney disease
Acronym
The comparative study between direct renin inhibitor and angiotensin II receptor antagonist
Scientific Title
The comparative study between direct renin inhibitor and angiotensin II receptor antagonist in hypertensive patients with chronic kidney disease
Scientific Title:Acronym
The comparative study between direct renin inhibitor and angiotensin II receptor antagonist
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine positioning of direct renin inhibitor in the hypertensive treatment of chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, Urinary albumin excretion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aliskiren fumarate
Interventions/Control_2
Valsartan
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with chronic kidney disease at stage 1-4
2) Patients prescribed angiotensin II receptor antagonist over one year
3) Patients prescribed angiotensin II receptor antagonist at most high dose
4) Patients with 150/90 mmHg or less of home blood pressure
Key exclusion criteria
1) Patients with a serious liver damage
2) Patients with a serious renal damage
3) Patients with serum potassium concentration over 5.5 mEq/L
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Okada |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology
Zip code
Address
30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Itabashi Hospital, Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology
Zip code
Address
TEL
03-3972-8111
Homepage URL
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Itabashi Hospital, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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 | 06 | Month | 24 | Day |
Last modified on
| 2012 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004602
