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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000255
Receipt No. R000000311
Scientific Title Additional JET Study for Patients during Maintenance Phase(Co-JET Study)
Date of disclosure of the study information 2005/10/01
Last modified on 2016/07/14

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Basic information
Public title Additional JET Study for Patients during Maintenance Phase(Co-JET Study)
Acronym Co-JET Study
Scientific Title Additional JET Study for Patients during Maintenance Phase(Co-JET Study)
Scientific Title:Acronym Co-JET Study
Region
Japan

Condition
Condition maintenance-phase renal failure (predialysis renal failure)
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of erythropoietin therapy on vital prognosis and hospitalization during the maintenance phase for anemia and renal failure management and therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Risk analysis of background factors affecting vital prognosis following initiation of hemodialysis is performed by the appropriate technique, such as Cox's regression model.
Key secondary outcomes Additionally, the same analysis is carried out with hospitalization as is done for vital prognosis.

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 All patients consenting to the present study of those registered in the Japan Erythropoietin Treatment Study for Target Hb and Survival (JET Study).
Key exclusion criteria no criteria
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SYUNJI YOKOYAMA
Organization Chugai Pharmaceutical CO.LTD.
Division name Drug Safety Unit
Zip code
Address 1-1MUROMACHI 2-CHOME, CHUO-KU TOKYO #103-8324, JAPAN
TEL 03-3273-0773
Email udagawayko@chugai-Pharm.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name SHIGERU NIHOJIMA
Organization Chugai Pharmaceutical CO.LTD.
Division name PHARMACOVIGILANCE Dept.
Zip code
Address 1-1MUROMACHI 2-CHOME, CHUO-KU TOKYO #103-8324, JAPAN
TEL 03-3273-0773
Homepage URL http://www.chugai-pharm.co.jp
Email nihojimasgr@chugai-pharm.co.jp

Sponsor
Institute Scientific Advisory Committee (SAC)
Institute
Department

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
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
2005 Year 10 Month 01 Day

Related information
URL releasing protocol http://www.chugai-pharm.co.jp
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Among registration cases, We were analysis on primary endpoint about 3,286 cases that a CRF was collected at dosage start time by Mar.,2009. 
3,280 patients after 6 patients were excluded as not eligible for analysis on the effects of treatment with rHuEPO on 1 y survival after beginning HD.As this result, in the rHuEPO treated group compared to the non-treatment group cumulative survivors were significantly higher, 98.59%, 97.10% and 95.36%, at 3, 6 and 12 mo after onset of HD, respectively.And the results were univariate analysis HR=0.47 (95%CI 0.34-0.64) and adjusted multivariate analysis HR=0.61 (95%CI 0.42-0.87).
2,434 patients after 852 patients were excluded as not eligible for analysis on the effect of rHuEPO treatment prior to HD on time to onset of HD .Effective covariates on the motivation to start rHuEPO treatment (IPW method) was seen in patients with higher sCre, greater age, hypertension or diabetes had a tendency to be treated with rHuEPO and patients with higher Hb or heart failure had a tendency to not be treated with rHuEPO.The adjusted hazard ratio of rHuEPO treatment on progression of CKD during the preHD period using IPW methods was 0.63 (95%CI 0.53&#8211;0.76; p<0.0001). Since stable weights could not be obtained with this analysis, a sensitivity analysis was performed. As a result, the hazard ratio appeared to be lower than 0.63.  
Influence of rHuEPO treatment before HD on progression of CKD using K-M method was also performed and the results were  as univariate analysis HR=0.46 (95%CI 0.42-0.51) and adjusted multivariate analysis HR=0.27 (95%CI 0.22-0.33).
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 06 Month 10 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2008 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information (1) Risk analysis of background factors affecting vital prognosis following initiation of hemodialysis is performed by the appropriate technique, such as Cox's regression model. Additionally, the same analysis is carried out with hospitalization as is done for vital prognosis.
(2) The relationship of the start of erythropoietin preparation during the maintenance phase to the disease state at the initiation of dialysis or renal anemia is investigated. Additionally, a risk analysis is conducted to assess prognostic factors(Hb during maintenance phase and manner and duration of the treatment for maintenance-phase renal failure) after initiation of dialysis.
(3) Shifts in clinical laboratory test findings before the initiation of hemodialysis are tabulated in figures and tables and analyzed appropriately.

Management information
Registered date
2005 Year 09 Month 30 Day
Last modified on
2016 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000311

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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