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

Chronic Kidney Disease Clinical Trial

— BRIGHTEN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136563
• Other study ID #: TRIGU1318
• Secondary ID: UMIN000013464
• Status: Completed
• Start date: April 2014
• Est. completion date: August 2019

Study information

• Verified date: June 2020
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Anemia
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Japan	Niigata University Graduate School of Medicine	Niigata

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Niigata University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Erythropoiesis resistance index (ERI)		For ninety six weeks after starting to administer darbepoetin alfa
Primary	Deterioration of renal function		For ninety six weeks after starting to administer darbepoetin alfa
Primary	Cardiovascular disease events		For ninety six weeks after starting to administer darbepoetin alfa
Secondary	Declination rate of estimated glomerular filtration rate(eGFR)		For ninety six weeks after starting to administer darbepoetin alfa
Secondary	Safety assessment for every adverse event resulting from darbepoetin alfa administration		For ninety six weeks after starting to administer darbepoetin alfa