N/A
N=393
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
Kidney Disease, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02547454 ↗Enrolled (actual)
393
Serious AEs
0.8%
Results posted
Nov 2015
Primary outcome: Primary: Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline — 22.8 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Methoxy polyethylene glycol-epoetin beta (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline |
22.8 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3 |
34 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6 |
35.1 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9 |
32.3 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12 |
35.2 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15 |
33.5 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18 |
31.4 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21 |
26 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months |
31.4 | — |
| PRIMARY Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline |
71.3 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3 |
77.2 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6 |
73.6 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9 |
74.1 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12 |
75.9 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15 |
78.2 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18 |
79.7 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21 |
75 | — |
| PRIMARY Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months |
68.6 | — |
| SECONDARY Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L |
NA | — |
| SECONDARY Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L |
NA | — |
| SECONDARY Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta |
88 | — |
| SECONDARY Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta |
100; 75; 75; 67; 50; 50 | — |
| SECONDARY Number of Dose Adaptations |
729; 11; 32; 314; 14; 213 | — |
| SECONDARY Percentage of Participants With Dose 0 |
32.6 | — |
| SECONDARY Percentage of Participants With Iron Replacement |
37.7; 31.6; 10.9; 19.8 | — |
Summary
This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.
Eligibility Criteria
Inclusion Criteria
- Participants aged > 18 years with CKD
- Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)
Exclusion Criteria
- Non-renal anemia
- Pregnancy and breast-feeding
- Uncontrolled hypertension
- Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
- Administration of any other study drug within 30 days prior to study enrollment
Data sourced from ClinicalTrials.gov (NCT02547454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.