Trial information
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
Status: Completed
Protocol number: BA16528
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of different dosing intervals of subcutaneous Mircera on hemoglobin level/correction in patients with chronic renal anemia
Brief summary: This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Target sample size is
54.
Study phase: II
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. Hemoglobin levels
Time frame: Throughout study
Key secondary outcomes: 1. Hematocrit, reticulocyte count. Vital signs, adverse events, laboratory values
Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Exclusion criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Canada
France
Mexico
Poland
United Kingdom
United States
- Birmingham, AL
- San Diego , CA
- Detroit, MI
- Las Vegas, NV
- Reno , NV
- Mineola, NY
- Portland, OR
