A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

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

Outcome

Met primary endpoint

paper The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (-0.05, 0.41), within a pre-defined non-inferiority limit. PMID 18586762 ↗

paper C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. PMID 18586762 ↗

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

Indications