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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003116
Receipt No. R000003780
Scientific Title Japan Erythropoietin Treatment-Strvey for starting hemoglobin level in renal anemia management
Date of disclosure of the study information 2010/02/01
Last modified on 2018/10/17

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Basic information
Public title Japan Erythropoietin Treatment-Strvey for starting hemoglobin level in renal anemia management
Acronym JET-STREAM
Scientific Title Japan Erythropoietin Treatment-Strvey for starting hemoglobin level in renal anemia management
Scientific Title:Acronym JET-STREAM
Region
Japan

Condition
Condition Renalanemic CKD patients in non-dialysis
Classification by specialty
Medicine in general Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of the survey is to investigate the impact on renal survival and renal function of different hemoglobin levels for initiating Epogin(Epoetin Beta) treatment in non-dialysis CKD patients with renal anemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Renal events:
Event days will be considered the days when the earliest of the following occurs. Individual events will also be analyzed. The date on which hemoglobin levels reach a certain value (e.g., 10 g/dL) instead of the first day of Epogin injection use will be employed as the beginning date to be used in evaluation.

1)Renal replacement therapy
2)Doubling time of creatinine level
3)eGFR<6.0 mL/min/1.73 m2
Key secondary outcomes (1)Endpoints related to renal function
Changes over time in hemoglobin levels, eGFR (rate of change, percentage of baseline eGFR), 1/Cr, and urinary protein and creatinine during the survey will be evaluated along with the relationships of these endpoints to patient background characteristics and event onset.

(2)Cardiovascular disease events
Event days will be considered the day of hospitalization or death due to any of the following cardiovascular diseases.

heart failure, angina pectoris, myocardial infarction, cerebral infarction, cerebral hemorrhage, transient ischemic attack

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 (1)Patients to register:
All non-dialysis CKD patients naive to erythropoiesis stimulating agent (ESA) therapy scheduled to start anemia treatment with Epogin Injection who will not likely introduce renal replacement therapy for at least six months and who could get informed consent to participate in the present survey.

(2)Patients for whom a survey form is to be collected: All registered patients who use Epogin
Key exclusion criteria The following patients will be excluded:
1)Patients with anemia caused by a condition other than renal anemia
2)Patients whose eGFR is less than 6 mL/min/1.73m2
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name JOJI MOCHIZUKI
Organization CHUGAI PHARMACEUTICAL CO.,LTD.
Division name DRUG SAFETY DEPT.
Zip code
Address 1-1 NIHONBASHI-MUROMACHI 2-CHOME,CHUO-KU TOKYO,103-8324 JAPAN
TEL 03-3273-0769
Email mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name IZUMI KAWASHIMA
Organization CHUGAI PHARMACEUTICAL CO.,LTD.
Division name PHARMACOVIGILANCE DEPT.
Zip code
Address PHARMACOVIGILANCE DEPT.
TEL 03-3273-0769
Homepage URL
Email kawashimaizm@chugai-pharm.co.jp

Sponsor
Institute CHUGAI PHARMACEUTICAL CO.,LTD.
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
2010 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://rd.springer.com/article/10.1007/s10157-015-1225-9
Number of participants that the trial has enrolled
Results
In this prospective, multi-center, observational study, non-dialysis CKD patients with anemia who were naive to erythropoiesis-stimulating agents (ESAs) were divided into 3 groups based on their Hb levels at initiation of epoetin beta therapy (Group I: 10 <= Hb < 11 g/dL, Group II: 9 <= Hb < 10 g/dL, and Group III: Hb < 9 g/dL). The primary endpoint was time to first occurrence of any renal event. For the primary analysis, an inverse probability weighted Cox regression model was used to adjust time-dependent selection bias in the artificially censored data.
A total of 1113 patients were eligible for primary endpoint analysis. Risk of renal events was significantly higher in Group III compared with Group I (HR, 2.52; 95% CI, 1.98 to 3.21; P < 0.0001); although not significant, the risk was also higher in Group II compared with Group I (HR, 1.48; 95% CI, 0.91 to 2.40; P = 0.11). 
Initiation of ESA therapy when Hb levels decreased below 11 g/dL but not below 10 g/dL could be more effective at reducing the risk of renal events in non-dialysis CKD patients with anemia compared with initiation of ESA therapy at below 9 g/dL or even 10 g/dL.
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
2009 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
2013 Year 07 Month 01 Day
Date trial data considered complete
2013 Year 11 Month 14 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information (1)Analysis population
The analysis population will consist of all patients fulfilling the registration criteria and for whom a survey form is collected provided the survey form indicates that Epogin was received at least once. An advisory committee will review and resolve any questions regarding patient handling (e.g., acceptance/rejection, inclusion in analysis population).
(2)Analyses and analytical methods
1)The effects of baseline hemoglobin levels on events will be evaluated. Given the likely presence of multiple groups (regimens) according to baseline hemoglobin levels, inverse probability weighting or another appropriate method will be used to estimate hazard ratios. The times to renal replacement therapy, doubling of creatinine, and eGFR<6.0 mL/min/1.73 m2 will be individually evaluated, as will the times to halving of eGRF<7.0 mL/min/1.73 m2, creatinine 6.0 mg/dL or more, and creatinine 8.0 mg/dL or more.
2)A statistical method similar to that used in "1)" will be used to evaluate the relationship between baseline hemoglobin levels and hospitalization events and deaths attributable to cardiovascular disease (i.e., cardiac failure, angina pectoris, myocardial infarction, cerebral infarction, cerebral hemorrhage, transient ischemic attack).
3)Cox regression will be used to evaluate factors impacting event occurrence.
4)Changes over time in hemoglobin levels, eGFR (rate of change, percentage of baseline eGFR), 1/Cr, and urinary protein and creatinine during the survey will be plotted on graphs and otherwise evaluated along with the relationships of these endpoints to patient background characteristics and event onset.

Management information
Registered date
2010 Year 01 Month 29 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003780

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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