N/A
Completed N=22
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)
Source: ClinicalTrials.gov NCT01417377 ↗Enrolled (actual)
22
Serious AEs
13.6%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study |
— | — |
| SECONDARY Time to Achieve Hb Level to 11-12 g/dL |
— | — |
| SECONDARY Number of Dose Adjustments Required to Maintain Hb Levels |
— | — |
| SECONDARY Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01417377). 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. Informational only — not medical advice.