Clinical trial NCT02136563: Renal Prognosis in Chronic Kidney Disease Patients With Hyporesponsive Anemia to Erythropoiesis Stimulating Agents
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia
Chronic Kidney Disease
Keywords: Chronic kidney disease
Erythropoiesis stimulating agent response index
Hyporesponsive anemia to erythropoiesis stimulating agent
Observational study
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Niigata University
First posted: 2014-05-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Deterioration of renal function
timeFrame: For ninety six weeks after starting to administer darbepoetin alfa
measure: Cardiovascular disease events
timeFrame: For ninety six weeks after starting to administer darbepoetin alfa
Secondary outcomes:
measure: Declination rate of estimated glomerular filtration rate(eGFR)
timeFrame: For ninety six weeks after starting to administer darbepoetin alfa
measure: Safety assessment for every adverse event resulting from darbepoetin alfa administration
timeFrame: For ninety six weeks after starting to administer darbepoetin alfa
Other outcomes:
measure: Erythropoiesis resistance index (ERI)
timeFrame: For ninety six weeks after starting to administer darbepoetin alfa
Locations:
city: Niigata
country: Japan
facility: Niigata University Graduate School of Medicine
Study officials:
affiliation: Niigata University Graduate School of Medicine
name: Ichiei Narita
role: PRINCIPAL_INVESTIGATOR
References: