Kidney Disease, ChronicNCT02263833
An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice
An observational study of Kidney Disease, Chronic, run by Hoffmann-La Roche at 1 site in South Korea.
Trial summary
This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- Mircera
- How many people
- 748 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Aug 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with chronic renal anemia regardless of pre-dialysis / dialysis in Korea. Participants who were prescribed Mircera by their physician according to the local Korean Mircera label, for the treatment of anemia associated with chronic kidney disease who require ESA therapy could be included in the study.
Who may be able to join
- Adult, aged >18 years
- Participants with stage 3-5 chronic kidney disease and hemodialyzed participants
- Signed informed consent
Who cannot join
- Current participation in a clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Surveillance of Mircera®
This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.
- Conditions
- Kidney Disease, Chronic
- Being tested
- Mircera
- 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.
MirceraDrug
Participants received Mircera according to individualized physician-prescribed regimen.
| Study group | Role | What they receive |
|---|---|---|
| Overall Participants | Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera Receives: Drug: Mircera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Measured: At physician's discretion, up to 4 years
Percentage of Participants With an Adverse Drug Reaction (ADR)
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
Measured: At physician's discretion, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263833
- Sponsor's protocol ID
- ML22560
- Status last verified
- Jul 2016
- First submitted
- 8 Oct 2014
- Last updated
- 7 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Mircera®
- ClinicalTrials.gov ID
- NCT02263833
- Acronym / sponsor ID
- ML22560
- Conditions
- Kidney Disease, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 28 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Participants | – | Drug: MirceraParticipants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic renal anemia regardless of pre-dialysis / dialysis in Korea. Participants who were prescribed Mircera by their physician according to the local Korean Mircera label, for the treatment of anemia associated with chronic kidney disease who require ESA therapy could be included in the study.
Key inclusion criteria (3 listed)
- Adult, aged >18 years
- Participants with stage 3-5 chronic kidney disease and hemodialyzed participants
- Signed informed consent
Key exclusion criteria (1 listed)
- Current participation in a clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirceraParticipants received Mircera according to individualized physician-prescribed regimen. | Drug | Overall Participants |
Primary outcome
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
Time frame: At physician's discretion, up to 4 years
An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Percentage of Participants With an Adverse Drug Reaction (ADR)
Time frame: At physician's discretion, up to 4 years
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clinical Trials study director
Hoffmann-La Roche
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 Kidney Disease, Chronic, run by Hoffmann-La Roche at 1 site in South Korea.
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 3 inclusion and 1 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 7 Sep 2016. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event (time frame: At physician's discretion, up to 4 years). 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?
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 7 Sep 2016.