UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003359 |
|---|---|
| Receipt number | 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 14:03:35 |
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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
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
h-yoko@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University School of Medicine, Division of Nephrology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004078
