A Phase 4 interventional study of methoxy polyethylene glycol-epoetin beta [Mircera] and Supportive treatment in Anemia, sponsored by Hoffmann-La Roche. Terminated at 20 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 1 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases 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]
Drug: Supportive treatment
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
As prescribed
Change in Hb concentration between baseline and efficacy evaluation period (EEP).
Time frame: Weeks 13-16
Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.
Time frame: Throughout study
SF36
Time frame: Weeks 16 and 48
AEs, laboratory parameters.
Time frame: Throughout study
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche