oBservational Clinical Research In Chronic Kidney Disease Patients With Renal Anemia : Renal proGnosis in Patients With Hyporesponsive Anemia To Erythropoiesis Stimulating Agents, darbepoetiN Alfa

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 site in 1 country2,000 target enrollmentApril 2014

ConditionsRenal Anemia Chronic Kidney Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Anemia
Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Enrollment: 2000
Locations: 1
Primary Endpoint: Cardiovascular disease events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

August 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Patients who are planning to start hemodialysis or to have a renal transplant within 24 weeks after enrollment,
•Patients with a history of treatment with ESA except the ones who were treated temporarily more than 12 weeks before the enrollment,
•Patients with malignant tumor, hematological disease, or hemorrhagic lesions,
•Patients with hypersensitivity to ESA or any ingredient thereof,
•Pregnant, lactating or possibly pregnant women or those who wish to become pregnant during the study period,
•Patients who are participating in other clinical study,
•Patients who are assessed as not eligible for the study by the investigator.

Outcomes

Primary Outcomes

Cardiovascular disease events

Time Frame: For ninety six weeks after starting to administer darbepoetin alfa

Deterioration of renal function

Time Frame: For ninety six weeks after starting to administer darbepoetin alfa

Secondary Outcomes

Declination rate of estimated glomerular filtration rate(eGFR)(For ninety six weeks after starting to administer darbepoetin alfa)
Safety assessment for every adverse event resulting from darbepoetin alfa administration(For ninety six weeks after starting to administer darbepoetin alfa)