Kidney Disease, Chronic
Conditions
Brief 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. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.
Interventions
DRUGMircera
Participants received Mircera according to individualized physician-prescribed regimen.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult, aged \>18 years * Participants with stage 3-5 chronic kidney disease and hemodialyzed participants * Signed informed consent
Exclusion criteria
* Current participation in a clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event | 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) | 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. |
Other
| Measure | Time frame |
|---|---|
| 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 | 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 | Up to 4 years |
Countries
South Korea
Participant flow
Pre-assignment details
In total, 748 participants were enrolled from 27 sites, of which only 742 participants were used for safety and efficacy analysis.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years. | 742 |
| Total | 742 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 14.2 |
| Sex: Female, Male Female | 376 Participants |
| Sex: Female, Male Male | 366 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 742 |
| serious Total, serious adverse events | 3 / 742 |
Outcome results
Primary
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
Population: Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Participants | Percentage of Participants With an Adverse Drug Reaction (ADR) | 2.0 percentage of participants |
Primary
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
Population: Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Participants | Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event | Adverse event | 3 percentage of participants |
| Overall Participants | Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event | Serious adverse event | 0.40 percentage of participants |
Other Pre-specified
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
Other Pre-specified
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