Anemia
Conditions
Brief summary
This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.
Interventions
DRUGMircera
Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.
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 patients, age 18 years or above * Chronic kidney disease (CKD) with anemia * Patients on dialysis receiving short-acting epoetin (EPO) * Serum ferritin level \>/=100 ng/ml or transferrin saturation (TSAT) \>/=20%
Exclusion criteria
* Patients unwilling to give informed consent * Uncontrolled hypertension * Transfusion of red blood cells within 8 weeks of the start of Mircera treatment * Relevant acute or chronic bleeding history * Hemolysis * Hemoglobinopathies * Pure red cell aplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study | Month 4 up to Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Achieve Hb Level to 11-12 g/dL | Up to 6 months |
| Number of Dose Adjustments Required to Maintain Hb Levels | Up to 6 months |
| Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC) | Up to 6 months |
Countries
Pakistan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mircera Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled, but not treated | 1 |
| Overall Study | Lost to Follow-up | 12 |
Baseline characteristics
| Characteristic | Mircera |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 16.8 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 22 |
| serious Total, serious adverse events | 3 / 22 |
Outcome results
Primary
Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
Time frame: Month 4 up to Month 6
Population: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.
Secondary
Number of Dose Adjustments Required to Maintain Hb Levels
Time frame: Up to 6 months
Population: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.
Secondary
Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)
Time frame: Up to 6 months
Population: The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL.
Secondary
Time to Achieve Hb Level to 11-12 g/dL
Time frame: Up to 6 months
Population: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.