Trial information
A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
Status: Recruiting
Protocol number: ML20884
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study of the effect of intravenous Mircera on the hemoglobin response rate in patients with chronic kidney disease who are on dialysis.
Brief summary: This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
104.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Hb response rate (increase in Hb >=1g/dL, and Hb concentration >=11g/dL, without RBC transfusion) Time frame: Weeks 0-24
Key secondary outcomes: 1. Hb values, change from baseline, time to Hb response Time frame: Throughout study
2. Incidence of RBC transfusions Time frame: Weeks 0-24
3. AEs, laboratory parameters, vital signs, ECGs Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.
Exclusion criteria:
- previous therapy with epoetin within 8 weeks prior to screening;
- overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
- RBC transfusions within 8 weeks before screening or during screening period;
- active malignant disease except non-melanoma skin cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2007
Trial registration date: 10/15/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Korea, Republic of
