Trial information
A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Status: Recruiting
Protocol number: ML20680
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study comparing the effect of Mircera and epoetin beta on hemoglobin response in patients with chronic kidney disease who are on dialysis
Brief summary: This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 360.
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 Time frame: Weeks 0-24
2. Change in Hb concentration between baseline and evaluation period Time frame: Months 4-6
Key secondary outcomes: 1. Hb over time Time frame: Throughout study
2. Time to Hb response Time frame: Throughout study
3. RBC transfusions Time frame: Weeks 0-24
4. AEs, laboratory parameters, vital signs Time frame: Throughout study
5. Serum concentration of Mircera Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia requiring dialysis;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
- adequate iron status.
Exclusion criteria:
- previous epoetin treatment within 8 weeks prior to screening;
- failing renal graft in place;
- bleeding episode necessitating transfusion within 8 weeks prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2007
Trial registration date: 03/07/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
China
- Beijing
- Chengdu
- Guangzhou
- Hangzhou
- Hong Kong
- Nanjing
- Shanghai
