UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008597 |
|---|---|
| Receipt number | R000010084 |
| Scientific Title | Impact of azilsartan on proteinuria in patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/08/05 |
| Last modified on | 2014/02/17 15:54:44 |
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Basic information
Public title
Impact of azilsartan on proteinuria in patients with chronic kidney disease
Acronym
Impact of azilsartan on proteinuria
Scientific Title
Impact of azilsartan on proteinuria in patients with chronic kidney disease
Scientific Title:Acronym
Impact of azilsartan on proteinuria
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the antiproteinuric effect of azilsartan to candesartan in the treatment of chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint is the difference of the percent changes in urinary protein creatinine ratio between two treatment groups
Key secondary outcomes
1. Changes of blood pressure
2. Changes of urinary protein creatinine ratio
3. eGFR
4. Changes of urinary angiotensinogen, urinary 8-OHdG, serum osteopontin, plasma MCP-1 and serum IL-6
5. Changes of urinary protein creatinine ratio and blood pressure after switching ARB, ACEI or DRI to azilsartan
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Azilsartan 20mg/day for 12 weeks
Interventions/Control_2
Candesartan 8mg/day for 12 weeks
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. Clinic SBP >130mmHg, clinic DBP >80mmHg or using anti-hypertensive drugs
2. Urinary protein creatinine ratio > 0.3g/gCr
3. eGFR >=15mL/min/1.73 m2
Key exclusion criteria
1. Pregnancy
2. History of hypersensitivity to azilsartan or candesartan
3. Myocardial infarction or stroke in the past 6 months
4. Potassium >= 5.5 mEq/L
5. During lactating
6. Liver dysfunction (ALT > 3-times the upper limit of normal)
7. IgA nephropathy starting steroid therapy within 1 year
8. Known bilateral renal artery stenosis
9. Severe nephrotic syndrome (serum alb < 2g/dL)
10. Active cancer
11. Severe infection
12. Judged as inappropriate for the study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
0926425256
tsuruya@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaichi Suehiro |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5256
Homepage URL
tsuehiro@gmail.com
Sponsor or person
Institute
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu 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
| 2012 | Year | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 06 | 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
| 2012 | Year | 08 | Month | 02 | Day |
Last modified on
| 2014 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010084
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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