N/A
N=108
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01695746 ↗Enrolled (actual)
108
Serious AEs
1.8%
Results posted
Jun 2016
Primary outcome: Primary: Mean Height of Participants at Baseline (Week 0) — 163.15 cm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- C.E.R.A. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Height of Participants at Baseline (Week 0) |
163.15 | — |
| PRIMARY Mean Weight of Participants at Baseline (Week 0) |
60.23 | — |
| PRIMARY Number of Participants With Co-morbidities at Baseline (Week 0) |
2; 4; 1; 1; 4; 1 | — |
| PRIMARY Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter) |
9.61 | — |
| PRIMARY Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value |
— | — |
| SECONDARY Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study |
90.2 | — |
| SECONDARY Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter) |
16.69 | — |
| SECONDARY Mean Dose of C.E.R.A. Administered |
75.5 | — |
| SECONDARY Number of Doses of C.E.R.A. Administered by Different Routes |
0; 572 | — |
| SECONDARY Number of Participants Who Received Concomitant Treatment for Anemia |
17; 15; 15; 2 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events |
4; 2 | — |
Summary
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.
Eligibility Criteria
Inclusion Criteria
- Adult patients, 18 to 65 years of age, inclusive
- Patients with stage III-IV chronic kidney disease not on dialysis
- Erythropoiesis stimulating agent (ESA) naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
- Adequate iron status as judged by the treating physician
Exclusion Criteria
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Clinically significant concomitant disease or disorder as defined by protocol
- Clinical suspicion of pure red cell aplasia (PRCA)
- Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
- Transfusion of red blood cells in the previous 2 months
- Pregnant women
- Contraindications for Mircera according to local prescribing information or as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT01695746). 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.