Renal Prognosis in Chronic Kidney Disease Patients With Hyporesponsive Anemia to Erythropoiesis Stimulating Agents

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02136563

Acronym

BRIGHTEN

Enrollment

2000

Registered

2014-05-13

Start date

2014-04-30

Completion date

2019-08-31

Last updated

2020-06-18

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

Conditions

Chronic Kidney Disease, Renal Anemia

Keywords

Chronic kidney disease, Erythropoiesis stimulating agent response index, Hyporesponsive anemia to erythropoiesis stimulating agent, Observational study

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

1. Patients who are planning to start hemodialysis or to have a renal transplant within 24 weeks after enrollment, 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 become 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

Measure	Time frame
Deterioration of renal function	For ninety six weeks after starting to administer darbepoetin alfa
Cardiovascular disease events	For ninety six weeks after starting to administer darbepoetin alfa

Secondary

Measure	Time frame
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

Other

Measure	Time frame
Erythropoiesis resistance index (ERI)	For ninety six weeks after starting to administer darbepoetin alfa

Countries

Japan

Outcome results