drugset / Trial / NCT00077766
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Timeline
- Start
- 2004-03
- Primary completion
- 2005-08
- Completion
- 2005-08
Publications
- Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloeguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | — | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 60 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 100 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 180 ug | Intravenous |