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oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa

oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa - BRIGHTEN

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000013464
Enrollment
2000
Registered
2014-04-01
Start date
2014-05-02
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

Renal anemia in chronic kidney disease

Interventions

None listed

Sponsors

Niigata University Graduate School of Medical & Dental Sciences
Lead Sponsor
Foundation for Biomedical Research and Innov ation at Kobe
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are planning to start treatment with darbepoetin alfa within 8 weeks after enrollment; 2) Patients with eGFR <60 mL/min/1.73m2 at the latest examination performed within 8 weeks before enrollment; 3) Patients with a hemoglobin level <11.0 g/dL at the latest examination performed within 8 weeks before enrollment; 4) Patients aged at least 20 years or older at the time of providing informed consent; 5) Patients who voluntarily provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Patients who are planning to start hemodialysis or renal transplantation within 24 weeks after enrolment; 2) Patients with a history of treatment with ESA except the ones who were treated temporarily more than 12 weeks before the enrollment; 3)Patients with malignant tumor, hematological disease, or hemorrhagic lesions; 4) Patients with hypersensitivity to ESA or any ingredient thereof; 5) Pregnant, lactating or possibly pregnant women or those who wish to be pregnant during the study period; 6) Patients who are participating in other clinical study; 7) Patients who are assessed as not eligible for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Deterioration of renal function, Cardiovascular disease events

Countries

Japan

Contacts

Public ContactTomoko Usui

The University of Tokyo Hospital Division of Nephrology and Endocrinology

usu-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026