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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001620
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Division of Kidney and Hypertension,Department of Internal Medicine,Jikei University,School of Medicine.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001947

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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