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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Renal Anemia

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• Japan
  • Niigata, Japan, 950-2181
    • Niigata University Graduate School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic renal disease patients without dialysis who are diagnosed with renal anemia and are administered darbepoetin alfa at enrollment

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Darbepoetin alfa

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Niigata University
• Investigators: Principal Investigator: Ichiei Narita, Niigata University Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Observational study; Erythropoiesis stimulating agent response index; Hyporesponsive anemia to erythropoiesis stimulating agent
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia
• Other Study ID Numbers: TRIGU1318; UMIN000013464 (Registry Identifier: UMIN-CTR)