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

Sponsors

Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborator: Niigata University

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

Overall Status Completed
Start Date April 2014
Completion Date August 2019
Primary Completion Date August 2019
Study Type Observational
Primary Outcome
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 Outcome
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
Enrollment 2000
Condition
Eligibility

Sampling Method: Probability Sample

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:

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.

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ichiei Narita Principal Investigator Niigata University Graduate School of Medicine
Location
Facility: Niigata University Graduate School of Medicine
Location Countries

Japan

Verification Date

June 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Darbepoetin alfa

Acronym BRIGHTEN
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov