drugset / Trial / NCT00077610
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 Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Timeline
- Start
- 2004-02
- 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.
- Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. doi: 10.1016/S0140-6736(07)61599-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin 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 | 120 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 180 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 200 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 360 ug | Intravenous |