Anemia Clinical Trial
Official title:
A Randomized, Open-label Study of the Effect of Maintenance Subcutaneous Mircera on Hemoglobin Levels in Dialysis Patients With Chronic Kidney Disease
Verified date | October 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Status | Completed |
Enrollment | 572 |
Est. completion date | March 2006 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients >=18 years of age; - chronic renal anemia; - on dialysis therapy for at least 12 weeks before screening; - receiving sc epoetin for at least 8 weeks before screening. Exclusion Criteria: - women who are pregnant, breastfeeding or using unreliable birth control methods; - administration of another investigational drug within 4 weeks before screening, or during the study period. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Belgium, Brazil, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Mexico, New Zealand, Panama, Poland, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in hemoglobin concentration | Weeks 1-36 | No | |
Secondary | Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration\n | Weeks 29-36 | No | |
Secondary | RBC transfusions | Weeks 1-36 | No | |
Secondary | AEs, laboratory parameters, vital signs | Throughout study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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