Phase 3
N=200
A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00576303 ↗Enrolled (actual)
200
Serious AEs
22.5%
Results posted
May 2016
Primary outcome: Primary: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP — 54.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining Average Hemoglobin Concentration Within +- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP |
— | — |
| SECONDARY Mean Change in Hb Concentration From Baseline to the EEP |
0.19 | — |
| SECONDARY Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP |
63.8 | — |
| SECONDARY Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP |
34.7 | — |
| SECONDARY Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP |
50; 37; 68; 41; 3; 81 | — |
| SECONDARY Number of Participants With Red Blood Cell Transfusion |
5 | — |
Summary
This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
- continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.
Exclusion Criteria
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B12 deficiency.
Data sourced from ClinicalTrials.gov (NCT00576303). 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.