A Phase 3 interventional study of methoxy polyethylene glycol-epoetin beta [Mircera] in Anemia, sponsored by Hoffmann-La Roche. Terminated at 22 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-05.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 4 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
Time frame: Week 32
Time to achievement of response
Time frame: Throughout study
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
Time frame: Throughout study
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
Time frame: Throughout study
Mean time spent in Hb range of 10.0 - 12.0g/dL
Time frame: Throughout study
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
Time frame: Throughout study
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche