drugset / Trial / NCT00364832
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Timeline
- Start
- 2001-10
- Primary completion
- 2005-07
- Completion
- 2005-07
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.
- Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79. doi: 10.1185/030079907x182103.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.4 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.8 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 1.2 ug/kg | Subcutaneous |