Completed

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

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Urogenital Diseases+9

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

Over 20 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: April 2014

See protocol details

Summary

Principal SponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

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.

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

NCT02136563

Principal SponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate

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,

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7 exclusion criteria prevent from participating

Pregnant, lactating or possibly pregnant women or those who wish to become pregnant during the study period,

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,

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Niigata University Graduate School of Medicine

Niigata, JapanOpen Niigata University Graduate School of Medicine in Google Maps

CompletedOne Study Center