|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00077597 |
Purpose
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Drug: epoetin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease |
| Enrollment: | 182 |
| Study Completion Date: | June 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv (starting dose) once every 2 weeks
|
| Active Comparator: 2 |
Drug: epoetin
3 times a week iv, as prescribed.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 60 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00077597 History of Changes |
| Other Study ID Numbers: | BA16736 |
| Study First Received: | February 10, 2004 |
| Last Updated: | May 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Anemia Hematologic Diseases Epoetin Alfa Hematinics |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |