UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002413 |
|---|---|
| Receipt number | R000002960 |
| Scientific Title | Assessment of the effects of telmisalthan and olmethaltan on inflammation and oxidative stress in patients on maintenance hemodialysis |
| Date of disclosure of the study information | 2009/09/15 |
| Last modified on | 2011/02/19 18:14:18 |
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Basic information
Public title
Assessment of the effects of telmisalthan and olmethaltan on inflammation and oxidative stress in patients on maintenance hemodialysis
Acronym
Impact of telmisalthan and olmethaltan on inflammation and oxidative stress
Scientific Title
Assessment of the effects of telmisalthan and olmethaltan on inflammation and oxidative stress in patients on maintenance hemodialysis
Scientific Title:Acronym
Impact of telmisalthan and olmethaltan on inflammation and oxidative stress
Region
| Japan |
Condition
Condition
Chronic kidney disease stage5d
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The angiotensin receptor blockers (ARBs) exert their antihypertensive effect through blockage of the angiotensin II as the class effect and have a true pleiotropic drug effects. The purpose of the study is to estimate the impact of telmisartan and olmesartan on inflammation and oxidative stress in patients on maintenance hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the impact of termisartan and olmesartan on blood pressure at 4, 12 and 24 months after administration of the ARB case compared with at baseline.
Key secondary outcomes
the secondary outcome is the impact of termisartan and olmesartan on inflammatory and oxidative stress markers (hsCRP, IL-6, IL-10. TNF, pentosidine, CML, PTX3, MPO, radical)at four and twelve months after administration of the ARB case compared with at baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
olmesartan
Interventions/Control_2
termisartan
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) Renal dysfunction: end-stage chronic kidney disease, require maintenance dialysis due to renal dysfunction
2) Expected survival time is more than 6 months
3) Aged 20 years over
4) Fully informed consent was obtained
Key exclusion criteria
1) Patients who has past history of adverse effect of taking another ARB
2) Pregnancy
3) Patients who has serious liver disease and coronary heart disease or nephrotic syndrome
4) Hemodialysis treatment for less than six months
5) Judged inappropriate for this study by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Michihata |
Organization
Ebara Clinic
Division name
Hemodialysis center
Zip code
Address
5-9-1 Koyama, Shinagawaku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROKAZU HONDA |
Organization
Showa University School of Medicine
Division name
Division of Nephrology Department of Medicine
Zip code
Address
TEL
Homepage URL
hondah@med.showa-u.ac.jp
Sponsor or person
Institute
Ebara Clinic
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology Department of Medicine Showa University School of Medicine
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 | 15 | 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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2011 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002960
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
