Anemia Clinical Trial
Official title:
An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease
Verified date | July 2011 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: National Agency of Medicines |
Study type | Interventional |
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients, >=18 years of age; - chronic kidney disease, stage 3 or 4; - anemia (baseline Hb between 9 and 11g/dL). Exclusion Criteria: - previous therapy with ESA within 12 weeks prior to screening; - overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening; - red blood cell transfusions within 8 weeks before screening; - active malignant disease (except non-melanoma skin cancer). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Estonia, Finland, Latvia, Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in Hb concentration between baseline and evaluation period | Weeks 29 to 36 | No | |
Secondary | Time to achievement of response, and mean time spent in Hb range of 11-13g/dL | Throughout study | No | |
Secondary | Percentage of patients maintaining Hb concentration of 11-13g/dL throughout evaluation period | Weeks 29-36 | No |
Status | Clinical Trial | Phase | |
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