NCT02136563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

5.3 years

First QC Date

May 7, 2014

Last Update Submit

June 17, 2020

Conditions

Renal AnemiaChronic Kidney Disease

Keywords

Chronic kidney diseaseErythropoiesis stimulating agent response indexHyporesponsive anemia to erythropoiesis stimulating agentObservational study

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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 Outcomes (1)

  • Erythropoiesis resistance index (ERI)

    For ninety six weeks after starting to administer darbepoetin alfa

Study Arms (1)

Darbepoetin alfa

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niigata University Graduate School of Medicine

Niigata, 950-2181, Japan

Location

Related Publications (1)

  • Nakai K, Nishino T, Kagimura T, Narita I. Impact of transferrin saturation on cardiovascular events in non-dialysis-dependent chronic kidney disease patients treated with darbepoetin alfa. J Nephrol. 2024 Nov;37(8):2327-2335. doi: 10.1007/s40620-024-02000-y. Epub 2024 Jun 28.

    PMID: 38941000DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ichiei Narita

    Niigata University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 13, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

JP(1)