The OROXAT "ALPINE" clinical efficacy and safety programme
A comprehensive range of Phase III clinical trials involving 9,600 patients
Included patients with non-dialysis-dependent, incident dialysis-dependent, and stable dialysis-dependent CKD.
Ast=Astellas trial
AZ=AstraZeneca trial
Fib=Fibrogen trial
*Darbepoetin-alfa active comparator
**Subset of patients with ≥2 weeks and ≤4 months of dialysis at the time of randomisation
†Epoetin-alfa active comparator
††Subset of patients with >4 months of dialysis at the time of randomisation
‡Darbepoetin-alfa or epoetin-alfa active comparator
CKD, chronic kidney disease; DD, dialysis-dependent; ESA, erythropoiesis-stimulating agent; Hb, haemoglobin; IV, intravenous; NDD, non-dialysis-dependent.
Reporting Adverse Events
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to SKF Pharma Ltd. on 0800 783 5018