Clinical Trial Protocol Registry

Trial information

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

Status:
Active, not recruiting
Protocol number:
ML25465
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A prospective study evaluating the efficacy and safety of Mircera in patients with CKD in predialysis and dialysis.
Brief summary:
This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment. Target sample size is 250.
Study phase:
IV
Study type:
Observational study
Conditions:
  • Anemia
  • Kidney Disease, Chronic
Primary outcome:
  1. Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines Time frame: 2 years
  2. Maintenance of target Hb range (10-12 g/dL) Time frame: 2 years
  3. Safety: Incidence of adverse events Time frame: 2 years
Key secondary outcomes:
  1. Correlation between baseline clinical variables and time on target Hb level Time frame: 2 years
  2. Dosing pattern in clinical practice, including dose adaptations Time frame: 2 years
  3. Frequency of visits and laboratory assessments Time frame: 2 years
  4. Effect of compliance to treatment on Hb levels Time frame: 2 years
Inclusion criteria:
  • Adult patients, >/= 18 years of age
  • Chronic kidney disease, in pre-dialysis or dialysis
  • Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics
Exclusion criteria:
  • Anemia due to non-renal causes
  • Pregnant or lactating women
  • Uncontrolled hypertension
  • Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
November, 2010
Trial registration date:
16.02.2011
Date last updated:
04.06.2013
This trial was conducted at the following locations:
ALBANIA
  • Tirane

Link to trial result

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