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NCT Number: NCT02136563

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

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.

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Key information

Conditions

Renal Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Niigata University Graduate School of Medicine

Niigata, 950-2181, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Deterioration of renal function

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

  2. Cardiovascular disease events

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

Secondary outcomes

  1. Declination rate of estimated glomerular filtration rate(eGFR)

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

  2. Safety assessment for every adverse event resulting from darbepoetin alfa administration

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

Other outcomes

  1. Erythropoiesis resistance index (ERI)

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Niigata University

Registry information

Official study title

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

Acronym: BRIGHTEN

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 13, 2014
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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