UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015671 |
|---|---|
| Receipt number | R000018210 |
| Scientific Title | Effects of Olmesartan and Azilsartan on biomarkers of progression of CKD and arteriosclerosis in CKD patients |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2018/02/22 09:38:26 |
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Basic information
Public title
Effects of Olmesartan and Azilsartan on biomarkers of progression of CKD and arteriosclerosis in CKD patients
Acronym
Effects of Olmesartan and Azilsartan on CKD patients
Scientific Title
Effects of Olmesartan and Azilsartan on biomarkers of progression of CKD and arteriosclerosis in CKD patients
Scientific Title:Acronym
Effects of Olmesartan and Azilsartan on CKD patients
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal efficacy of Olmesartan and Azilsartan on progression of CKD and arteriosclerosis by using specific biomarkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in CKD biomarkers such as urinary protein, urinary L-FABP and renal hypoxia measured by BOLD-MRI, and CAVI as an arteriosclerosis biomarker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-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
Treat patients with Olmesartan (20mg) for 6 months, and then change it with Azilsartan (20mg) and treat them for additional 6 months. Measure biomarkers on 0, 6, and 12 months.
Interventions/Control_2
Treat patients with Azilsartan (20mg) for 6 months, and then change it with Olmesartan (20mg) and treat them for additional 6 months. Measure biomarkers on 0, 6, and 12 months.
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
CKD stage G3b to G4, and A2 to A3
uncontrolled high blood pressure (>130/80) under treatment with antihypertensives other than ARB
Key exclusion criteria
Allergy to ARB
Liver dysfunction
Pregnancy
Inappropriate patients judged by their physiocians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Okada |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Morohongo, Moroyama-cho, Irumagun, Saitama 350-0451, Japan
TEL
049-276-1611
hirookda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Inoue |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Morohongo, Moroyama-cho, Irumagun, Saitama 350-0451, Japan
TEL
049-276-1611
Homepage URL
t_inoue@saitama-med.ac.jp
Sponsor or person
Institute
Department of Nephrology, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Saitama Medical 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
| 2014 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 22 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 12 | Day |
Last modified on
| 2018 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018210
