Clinical Trial Protocol Registry

Trial information

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

Status:
Active, not recruiting
Protocol number:
ML25317
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
The comparison of the monthly mean dosage of MIRCERA betwen the titration phase and the maintenance phase of the treatment in patients with CKD who are not on dialysis
Brief summary:
This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months. Target sample size is 403.
Study phase:
IV
Study type:
Observational study
Conditions:
  • Kidney Disease, Chronic
Primary outcome:
  1. Observation of monthly mean dose of Mircera during the titration and the maintenance period in patients not on dialysis Time frame: 10 months
Key secondary outcomes:
  1. Hemoglobin level in erythropoiesis stimulating agent naive patients before the administration of Mircera Time frame: 10 months
  2. Hemoglobin level in erythropoeisis stimulating agent treated patients before and after the conversion to Mircera Time frame: 10 months
Inclusion criteria:
  • Adults patients, >/=18 years of age
  • Presence of chronic kidney disease (Stage 3-4)
Exclusion criteria:
  • Participation in another clinical study
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
July, 2010
Trial registration date:
16.12.2010
Date last updated:
04.06.2013
This trial was conducted at the following locations:
Czech Republic
  • NOVY JICIN

Link to trial result

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