An observational study in Kidney Disease, Chronic, sponsored by Hoffmann-La Roche. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by Hoffmann-La Roche · Observational
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 748 is above the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera
Drug: Mircera
Participants received Mircera according to individualized physician-prescribed regimen.
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.
Time frame: 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.
Time frame: At physician's discretion, up to 4 years
Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion
Time frame: Up to 4 years
Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL
Time frame: Up to 4 years
| Milestone | Overall Participants |
|---|---|
| Started | 742 |
| Completed | 742 |
| Not completed | 0 |
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 | Overall Participants |
|---|---|
| Adverse event | 3 |
| Serious adverse event | 0.40 |
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.
| percentage of participants | Overall Participants |
|---|---|
| Percentage of Participants With an Adverse Drug Reaction (ADR) | 2.0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Up to 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Participants | — | 3/742 (0.4%) | 0/742 (0%) |
| Event | Overall Participants |
|---|---|
| Atrioventricular blockCardiac disorders | 1/742 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/742 |
| Pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 1/742 |
| Age, Continuous(years) | Overall Participants |
|---|---|
| Mean | 58.7 ± 14.2 |
| Sex: Female, Male(Participants) | Overall Participants |
|---|---|
| Female | 376 |
| Male | 366 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →