Phase 2
N=91
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00048035 ↗Enrolled (actual)
91
Serious AEs
44.0%
Results posted
Dec 2016
Primary outcome: Primary: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen — -0.29; -0.92; -0.04; -0.46 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen |
-0.29; -0.92; -0.04; -0.46; 0.86; -0.07 | — |
| SECONDARY Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen |
-1.50; -3.01; -0.32; -1.62; 2.73; -0.07 | — |
| SECONDARY Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths |
42; 37; 20; 20; 3; 2 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
3; 1; 3; 4; 4; 2 | — |
| SECONDARY Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis |
-2; -1; -10; -8; -6; -10 | — |
| SECONDARY Mean Change in Pulse Rate |
-1; 1; 2; 3; -1; 3 | — |
Summary
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- chronic renal anemia;
- on hemodialysis therapy for at least 3 months;
- receiving iv epoetin alfa during the 2 weeks prior to the run-in period.
Exclusion Criteria
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
Data sourced from ClinicalTrials.gov (NCT00048035). 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.