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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002413
Receipt No. 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

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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
Email

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
Email hondah@med.showa-u.ac.jp

Sponsor
Institute Ebara Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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