Phase 4
N=70
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01342640 ↗Enrolled (actual)
70
Serious AEs
10.0%
Results posted
Oct 2015
Primary outcome: Primary: Change From Baseline in Mean Hb Concentration at Week 20 — 8.820; 1.440 Grams per deciliter (gm/dL) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Hb Concentration at Week 20 |
8.820; 1.440 | <0.0001 sig |
| PRIMARY Change From Baseline in Mean Hb Concentration at Week 24 |
1.470 | <.0001 sig |
| PRIMARY Change From Baseline in Mean Hb Concentration at Week 28 |
1.680 | <.0001 sig |
Summary
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
Eligibility Criteria
Inclusion Criteria
- Adult patients, age >/=18 years
- Diagnosis of chronic renal anemia
- Not on dialysis
- Hemoglobin concentration /=20 ml/min
- Adequate iron status
Exclusion Criteria
- Transfusion of red blood cells during the previous 2 months
- Poorly controlled hypertension
- Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
- Active malignant disease (except non-melanoma skin cancer)
- Hemolysis
- Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
Data sourced from ClinicalTrials.gov (NCT01342640). 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.