UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000254 |
|---|---|
| Receipt number | R000000148 |
| Scientific Title | Japan Erythropoietin Treatment Study for Target Hb and Survival |
| Date of disclosure of the study information | 2005/10/01 |
| Last modified on | 2024/03/15 16:01:24 |
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Basic information
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
Condition
Renal anemia under hemodialysis
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
yokoyamasnj@chugai-pharm.co.jp
Public contact
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
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Scientific Advisory Committee (SAC)
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO.LTD.
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
NA
Address
NA
Tel
NA
NA
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
| 2005 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.chugai-pharm.co.jp/
Publication of results
Published
Result
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 ≥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
Progress
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
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.
Management information
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
