An observational study in Anemia, sponsored by Hoffmann-La Roche. Completed at 109 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Hoffmann-La Roche · Observational
This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's enrollment of 815 is above the median of 200 across 331 observational studies indexed under Anemia.
Browse Anemia studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation), initiating treatment with Mircera, and erythropoiesis-stimulating agent (ESA)-naïve or not
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Exclusion Criteria:
Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6
Time frame: 6 months
Biological parameters: hemoglobin concentration at each observation time point.
Time frame: 6 months
Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6
Time frame: 6 months
Dose/schedule of Mircera treatment at each observation timepoint
Time frame: 6 months
Concomitant medication/treatments in the management of anemia
Time frame: 6 months
Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera
Time frame: Month 6
Change in hemoglobin level
Time frame: from baseline to Month 6
Safety: Incidence of adverse events
Time frame: 6 months
Showing the first 100 of 109 sites.
The record gives a start of May 2011, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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