UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008989 |
|---|---|
| Receipt number | R000010541 |
| Scientific Title | Effect and safety of conversion from Candesartan to Azilsartan in renal transplant recipeints |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2017/05/22 17:40:26 |
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Basic information
Public title
Effect and safety of conversion from Candesartan to Azilsartan in renal transplant recipeints
Acronym
Conversion to Azilsartan in kidney trasnplant recipients
Scientific Title
Effect and safety of conversion from Candesartan to Azilsartan in renal transplant recipeints
Scientific Title:Acronym
Conversion to Azilsartan in kidney trasnplant recipients
Region
| Japan |
Condition
Condition
hypertensive patient
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess beneficial effect and safety of convesrion from Azilsartan from Candesartan in renal translant patients with hypertension and proteinuria
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urine protein before,3 months,6 months,and 12 months after the conversion
Key secondary outcomes
Blood pressure,albumin,creatinen,potasium,hemoglubin,plasma renin activity,plasma aldosterone concentarion and MCP-1 before,3 months,6 months,and 12 months after the conversion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
20mg Azilsartan qd for 12wks,40mg qd for 40wks
Interventions/Control_2
8mg Candesartan qd for 52wks
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
Renal transplant recipients with grater than 200mg/day of urine protein despite of the treatment of 12mg Candesartan qd
Key exclusion criteria
1)Past medical history of hypersensitivity to azilsartan
2)Pregnant,lactating,and possibly pregnant women and those planning to become pregnant
3)Judged as ineligible by clinical investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Kakuta |
Organization
Osaka University Greduate School of Medicine
Division name
Department of Urology
Zip code
Address
2-2 E4 Yamada-oka,Suita,Osaka,Japan
TEL
06-6879-3531
kakuta@uro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Kakuta |
Organization
Osaka University Greduate School of Medicine
Division name
Department of Urology
Zip code
Address
2-2 E4 Yamada-oka,Suita,Osaka,Japan
TEL
06-6879-3531
Homepage URL
kakuta@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
Soryukai Inoue Hospital
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
| 2012 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 22 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 22 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010541
