Renal AnemiaBRIGHTENNCT02136563
Renal Prognosis in Chronic Kidney Disease Patients With Hyporesponsive Anemia to Erythropoiesis Stimulating Agents
An observational study of Renal Anemia and Chronic Kidney Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Anemia, Chronic Kidney Disease
- How many people
- 2,000 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2014to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic renal disease patients without dialysis who are diagnosed with renal anemia and are administered darbepoetin alfa at enrollment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Renal Anemia, Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Erythropoiesis stimulating agent response index, Hyporesponsive anemia to erythropoiesis stimulating agent, Observational study
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deterioration of renal function
Measured: For ninety six weeks after starting to administer darbepoetin alfa
Cardiovascular disease events
Measured: For ninety six weeks after starting to administer darbepoetin alfa
Secondary outcomes (2)
Declination rate of estimated glomerular filtration rate(eGFR)
Measured: For ninety six weeks after starting to administer darbepoetin alfa
Safety assessment for every adverse event resulting from darbepoetin alfa administration
Measured: For ninety six weeks after starting to administer darbepoetin alfa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Niigata University
- Responsible party
- Sponsor
- Investigators
- Ichiei Narita, Principal investigator, Niigata University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136563
- Sponsor's protocol ID
- TRIGU1318
- Other IDs
- UMIN000013464
- Acronym
- BRIGHTEN
- Status last verified
- Jun 2020
- First submitted
- 7 May 2014
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38941000
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02136563
- Acronym / sponsor ID
- BRIGHTEN / TRIGU1318
- Conditions
- Renal Anemia, Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Erythropoiesis stimulating agent response index, Hyporesponsive anemia to erythropoiesis stimulating agent, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Niigata University
- Study start
- Apr 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic renal disease patients without dialysis who are diagnosed with renal anemia and are administered darbepoetin alfa at enrollment
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deterioration of renal function
Time frame: For ninety six weeks after starting to administer darbepoetin alfa
Cardiovascular disease events
Time frame: For ninety six weeks after starting to administer darbepoetin alfa
2 secondary outcomes
Declination rate of estimated glomerular filtration rate(eGFR)
Time frame: For ninety six weeks after starting to administer darbepoetin alfa
Safety assessment for every adverse event resulting from darbepoetin alfa administration
Time frame: For ninety six weeks after starting to administer darbepoetin alfa
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 38941000Nakai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ichiei Narita principal investigator
Niigata University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Anemia and Chronic Kidney Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deterioration of renal function (time frame: For ninety six weeks after starting to administer darbepoetin alfa). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.