Japan Erythropoietin Treatment-Strvey for starting hemoglobin level in renal anemia management

Japan Erythropoietin Treatment-Strvey for starting hemoglobin level in renal anemia management - JET-STREAM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000003116

Enrollment

2000

Registered

2010-02-01

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renalanemic CKD patients in non-dialysis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactIZUMI KAWASHIMA

CHUGAI PHARMACEUTICAL CO.,LTD. PHARMACOVIGILANCE DEPT.

kawashimaizm@chugai-pharm.co.jp03-3273-0769

Outcome results