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


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 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


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

Value
https://center6.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