UMIN-CTR Clinical Trial

Public title

Japan Erythropoietin Treatment Study for Target Hb and Survival

Acronym

JET Study

Scientific Title

Japan Erythropoietin Treatment Study for Target Hb and Survival

Scientific Title:Acronym

JET Study

Region

Japan

Condition

Renal anemia under hemodialysis

Classification by specialty

Nephrology

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of the present prospective study is to ascertain the optimal target Hb with respect to vital prognosis and hospitalization for the treatment of renal anemia using Epogin® Injection in maintenance hemodialysis patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The relationship between maintenance Hb and vital prognosis (survival) at six months after the start of Epogin® Injection administration is investigated, and the optimal target Hb is established with respect to vital prognosis.

Key secondary outcomes

(1) As with vital prognosis (survival), the optimal target Hb is investigated in relation to hospitalization. However, hospitalization due to testing or social purposes is excluded.
(2) The effects of erythropoietin therapy during the maintenance phase on vital prognosis and hospitalization following the initiation of dialysis are investigated.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled to start Epogin® Injection administration within one year of initiation of hemodialysis and scheduled to continue receiving Epogin® Injection for at least 180 days to treat renal anemia occurring during dialysis.
Also eligible are patients scheduled to be transferred to a maintenance dialysis facility where Epogin ® Injection is available.

Key exclusion criteria

1) Patients undergoing other types of dialysis – e.g., CAPD, HDF, or HF
2) Patients undergoing hemodialysis and another type of dialysis simultaneously
3) Patients who have undergone other types of dialysis prior to hemodialysis
4) Patients in whom dialysis has been terminated, then resumed
5) Patients who have received another erythropoietin preparation after initiation of hemodialysis
6) Patients who do not give informed consent

Target sample size

10000

Name of lead principal investigator

1st name	SYUNJI
Middle name
Last name	YOKOYAMA

Organization

CHUGAI PHARMACEUTICAL CO.LTD.

Division name

Drug Safety Unit

Zip code

103-8324

Address

1-1 Muromachi 2 Cho-me, Nihonbashi, Chuou-Ku, Tokyo, #103-8324, JAPAN

TEL

03-3273-0773

Email

yokoyamasnj@chugai-pharm.co.jp

Name of contact person

1st name	Ayako
Middle name
Last name	Murayama

Organization

CHUGAI PHARMACEUTICAL CO.LTD.

Division name

Drug Safety Div.

Zip code

103-8324

Address

1-1 Muromachi 2 Cho-me, Nihonbashi, Chuou-Ku, Tokyo, #103-8324, JAPAN

TEL

070-4427-0437

Homepage URL

http://www.chugai-pharm.co.jp

Email

murayamaayk@chugai-pharm.co.jp

Institute

Scientific Advisory Committee (SAC)

Institute

Department

Personal name

Organization

CHUGAI PHARMACEUTICAL CO.LTD.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NA

Address

NA

Tel

NA

Email

NA

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2005

Year

10

Month

01

Day

URL releasing protocol

http://www.chugai-pharm.co.jp/

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Although erythropoiesis stimulating agents (ESA) may be beneficial for prolonging the survival of hemodialysis patients with anemia, association between hemoglobin (Hb) level and treatment outcome is still unclear, especially for the Japanese population. The Japan Erythropoietin Treatment (JET) Study, an open multi-center, prospective, observational study, was designed to evaluate the relationship between the maintenance of Hb levels and patient prognoses after the first administration of epoetin beta to new hemodialysis patients. Among a total of 10,310 patients, 6631 completed the initial 6 months of epoetin beta treatment (induction phase) and were followed up for a further 2.5 years (maintenance phase). Three-year survival rate of patients with <9 g/dL Hb levels after 6 months was 74.1%, which was significantly lower than 89.3% for patients with Hb levels 10-11 g/dL (reference group); the adjusted hazard ratio (HR) was 2.08 (95% CI, 1.57 to 2.77; p<0.0001). Moreover, the 3-year survival rate for poor responders with Hb levels <10 g/dL and weekly epoetin beta doses &#8805;9000 IU during the induction phase was 71.6%, which was significantly lower than 89.4% for the reference group, excluded poor responders and unstable responders, as a control group, and the HR was 1.71 (95% CI, 1.13 to 2.60; p=0.0118). Adverse events related to the treatment were reported in 71 of 10,310 patients (0.69%). These findings of the JET study indicate that the achieved low Hb levels and poor response to ESA therapy might be strongly associated with high mortality.

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

Recruitment status

Completed

Date of protocol fixation

2005

Year

04

Month

08

Day

Date of IRB

Anticipated trial start date

2005

Year

10

Month

01

Day

Last follow-up date

2011

Year

09

Month

01

Day

Date of closure to data entry

2012

Year

01

Month

01

Day

Date trial data considered complete

2012

Year

03

Month

01

Day

Date analysis concluded

2012

Year

10

Month

01

Day

Other related information

(1) At 180 days after the start of administration, the subjects are divided into five hemoglobin groups (Group 1:more 12 g/dL, Group 2: more 11 but <12 g/dL, Group 3: more10 but <11 g/dL, Group 4 : more 9 but <10 g/dL and Group 5 :<9 g/dL), and the Kaplan-Meier method is used to draw survival curves and to calculate 1-3 year survival rates to ascertain the optimal Hb. Factors other than hemoglobin, such as diabetes, are adjusted by the appropriate technique, such as Cox's regression model. As with vital prognosis, the results are also analyzed from the viewpoint of hospitalization.
(2) The effects of erythropoietin therapy during the maintenance phase on vital prognosis and hospitalization following the initiation of dialysis are also analyzed.
(3) As to the shifts in clinical laboratory findings, key statistics are calculated for each group and time point, tabulated in figures and charts, and analyzed by an appropriate test (t-test of log data).
(4) The incidence of adverse reactions for each group and background factor is calculated to assess safety.

Registered date

2005

Year

09

Month

30

Day

Last modified on

2024

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000148