Phase 3
N=424
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00413894 ↗Enrolled (actual)
424
Serious AEs
41.0%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase — 31.7 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
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase |
31.7 | — |
| PRIMARY Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase |
75.6 | — |
| PRIMARY Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase |
44.9; 17.5 | — |
| PRIMARY Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase |
88.8; 61.5 | — |
| SECONDARY Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase |
36.8 | — |
| SECONDARY Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase |
91.6 | — |
| SECONDARY Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase |
43.4; 21.9 | — |
| SECONDARY Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase |
93.1; 88.3 | — |
| SECONDARY Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels |
59.4; 19.5; 4.3; 14.9 | — |
| SECONDARY Percentage of Participants With Hb Fluctuations Within Evaluation Phase |
82.9; 7.9; 2.9; 0.5; 5.8 | — |
| SECONDARY Percentage of Participants With Hb Fluctuations Within Screening Phase |
90.6; 8.7; 0.7 | — |
| SECONDARY Percentage of Participants Requiring Erythrocyte Transfusions |
0.7; 5.0 | — |
Summary
This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin 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 500+ individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- chronic renal anemia;
- longterm hemodialysis for >=12 weeks before screening;
- baseline Hb between 10 and 13g/dL;
- iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.
Exclusion Criteria
- acute or chronic bleeding within 8 weeks prior to screening;
- transfusion of red blood cells within 8 weeks prior to screening;
- poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
- previous treatment with Mircera.
Data sourced from ClinicalTrials.gov (NCT00413894). 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.