Multicentre, double-blind, randomised controlled trial1
FERACCRU® Clinical Data - Chronic Kidney Disease (CKD)
AEGIS-CKD: phase III trial to evaluate the efficacy of oral ferric maltol vs placebo to treat iron deficiency anaemia (IDA) in patients with stage 3 or 4 CKD1
Key inclusion criteria:
Patients aged ≥18 years
Ferritin <250 µg/L + transferrin saturation (TSAT) <25% or ferritin <500 µg/L + TSAT <15%
Hb ≥8.0 to <11.0 g/dL
CKD (eGFR ≥15 to <60 mL/min/1.73m2)
Key exclusion criteria:
Anemia due to any cause other than iron deficiency
Oral iron supplementation within two weeks, intravenous iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within the previous 12 weeks.
Renal transplant within 12 months prior to randomization
Please refer to Clinical Trials https://clinicaltrials.gov/ct2/show/NCT02968368 for more information
BID, twice daily; eGFR, estimated glomerular filtration rate; Hb, haemoglobin; TSAT, transferrin saturation
In patients with CKD stage 3 or 4, FERACCRU® resulted in statistically significant increases in Hb concentration, Ferritin and TSAT from baseline to week 16 vs placebo1
Significant increase in Hb levels after 16 weeks1
(Primary Endpoint)
Adapted from Pergola PE et al, 2021
Adapted from Pergola PE et al, 2021
*Least-Square-Mean change from baseline after 16 weeks
FERACCRU® was well-tolerated vs placebo1
Incidence of adverse events at week 16 (pre-planned safety set)1
• Only minor differences were noted in the safety profile and overall GI AEs vs placebo
• Gastrointestinal AEs included diarrhoea, nausea, constipation and discoloured faeces
Adapted from Pergola PE et al, 2021
A higher proportion of patients on FERACCRU® completed 16 weeks of treatment vs placebo:
• FERACCRU® 81% (n=90/111)
• Placebo 70% (n=39/56)
1. Pergola PE, Kopyt NP. Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. Am J Kidney Dis. 2021