UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001620 |
|---|---|
| Receipt number | R000001947 |
| Scientific Title | A multi-center randomized control trial on Target hemoglobin for REnal function and clinical outcomes in Non-Dialysis patients in Japan (TREND-J Study) |
| Date of disclosure of the study information | 2009/01/15 |
| Last modified on | 2010/07/21 12:23:24 |
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Basic information
Public title
A multi-center randomized control trial on Target hemoglobin for REnal function and clinical outcomes in Non-Dialysis patients in Japan (TREND-J Study)
Acronym
TREND-J Study
Scientific Title
A multi-center randomized control trial on Target hemoglobin for REnal function and clinical outcomes in Non-Dialysis patients in Japan (TREND-J Study)
Scientific Title:Acronym
TREND-J Study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease(stage3/4/5,CKD)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate target hemoglobin(Hb) levels in CKD3-4 patients treated with rHuEPO in terms of renal function, cardiovasclar events(hospitalization), and QOL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Renal survival(time to creatinine doubling and renal replacement therapy, or death)
Key secondary outcomes
1)achievement ratio to the targeted Hb levels
2)rate of change of eGFR
3)change of protein contents in urine(adjusted by creatinine)
4)hospitalization by cardiovascular diseases
5)change of cardiac functions(LVMI, EF)
6)QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
C group:Hb level targeted to 10g/dL(within 9.5-10.5g/dL)
Interventions/Control_2
H group:Hb level targeted to 12g/dL(within 11.5-12.5g/dL)
If patients with Hb level above 11.0g/dL are automatically allocated to H group
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)patients treated or planing to treat with rHuEPO
2)patients in stage 3,4 or 5 CKD (eGFR:<60)
3)patients expected not to start renal replace therapy
Key exclusion criteria
1)patients with anemia other than renal anemia(such as hematological disorders)
2)patients needed hospitalization by cardiovascular diseases within the past half year
3)patients with malignant tumor
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Hosoya |
Organization
The Jikei University, School of Medicine.
Division name
Division of Kidney and Hypertension, Department of Internal Medicine.
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo 105-8461, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Yamamoto |
Organization
The Jikei University, School of Medicine.
Division name
Division of Kidney and Hypertension, Department of Internal Medicine.
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo 105-8461, Japan.
TEL
03-3433-1111
Homepage URL
http://trend-J.rinsho-kenkyu.net
Sponsor or person
Institute
Division of Kidney and Hypertension,Department of Internal Medicine,Jikei University,School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
The Jikei University, School of Medicine
Division of Kidney and Hypertension, Department of Internal 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 | 01 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2010 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001947
