FERACCRU® was effective in patients with IDA and stage 3/4 CKD without concomitant erythropoietin1,2
FERACCRU® achieved a statistically significant and clinically meaningful increase in mean Hb levels vs placebo at 16 weeks1
AEGIS-CKD 16-week study design1,3
Phase 3, randomised, double-blind, placebo-controlled, multicentre study
- Change in Hb concentration from baseline to Week 16 (ITT population)
- ≥1 g/dL and ≥2 g/dL Hb increases at Week 16
- Hb ≥11 g/dL at Week 16
- Hb changes from baseline to Week 4 and Week 8
- Changes in ferritin, TSAT and serum iron
- Treatment-emergent AEs and SAEs
Mean change in Hb concentration over 52 weeks’ treatment without erythropoietin1,2
FERACCRU® achieved statistically significant improvements in ferritin, TSAT and serum iron vs placebo1
Mean change from baseline to Week 161
FERACCRU® was generally well tolerated1
AEGIS-CKD long-term extension study design2
- Change from baseline to Week 52 in Hb, ferritin, TSAT and serum iron
Incidence of treatment-emergent AEs occurring in ≥5% of stage 3/4 CKD patients over 16 weeks’ treatment3
Adapted from Data on File – Kopyt NP, et al. AEGIS CKD oral presentation, ASN Kidney Week 2018.
AE, adverse event; CKD, chronic kidney disease; Hb, haemoglobin; IBD, inflammatory bowel disease; IDA, iron deficiency anaemia; ITT, intention to treat; SAE, serious adverse event; TSAT, transferrin saturation.
- Kopyt NP, et al. J Am Soc Nephrol 2018;29:70–71 (abstract number FR-OR120).
- Pergola PE, et al. Presented at ASN 2019, poster number TH-PO451.
- Data on File – Kopyt NP, et al. AEGIS CKD oral presentation, ASN Kidney Week 2018.