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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003359
Receipt No. R000004078
Scientific Title Evaluation of renal protection by irbesartan and losartan in renal transplanted patients
Date of disclosure of the study information 2010/04/01
Last modified on 2012/09/20

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Basic information
Public title Evaluation of renal protection by irbesartan and losartan in renal transplanted patients
Acronym I-LORD study
Scientific Title Evaluation of renal protection by irbesartan and losartan in renal transplanted patients
Scientific Title:Acronym I-LORD study
Region
Japan

Condition
Condition renal transplantation
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate which renoprotective hypotensive agent irbesartan or losartan is superior for renal protective action in renal transplanted patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes alteration rate of eGFR
serum cretinine levels
Key secondary outcomes clinic blood pressure
urinary MCP-1
albuminuria

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 irbesartan 50 or 100mg, max 200mg
Interventions/Control_2 losartan 25 or 50mg, max 100mg
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 patients with hypertension based on a guidline of JSH2009
Key exclusion criteria renal failure (serum creatinine more than 2.5mg/dL)
Child bearing women
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Yokoyama
Organization Kanazawa Medical University, School of Medicine
Division name Division of Nephrology
Zip code
Address 1-1 Daigaku, Uchinada, Ishikawa
TEL 076-286-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Yokoyama
Organization Kanazawa Medical University, School of Medicine
Division name Division of Nephrology
Zip code
Address 1-1 Daigaku, Uchinada, Ishikawa
TEL 076-286-2211
Homepage URL
Email h-yoko@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University School of Medicine, Division of Nephrology
Institute
Department

Funding Source
Organization Kanazawa Medical University School of Medicine, Division of Nephrology
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 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2010 Year 04 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
2010 Year 01 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 19 Day
Last modified on
2012 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004078

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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