Anemia
Conditions
Brief summary
This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is \<100 individuals.
Interventions
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * chronic kidney disease; * anemia (Hb \>8 and \<11 g/dL); * regular dialysis or predialysis, not treated with ESA.
Exclusion criteria
* transfusion of red blood cells during previous 8 weeks; * poorly controlled hypertension; * overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks; * active malignant disease (except melanoma of skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients | 24 weeks after first dose, through week 25 |
Secondary
| Measure | Time frame |
|---|---|
| >=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments | At end of 24 weeks treatment |
Countries
Philippines
Outcome results
None listed