Abstract: TH-PO451
Efficacy and Safety of Oral Ferric Maltol in Treating Iron-Deficiency Anemia in Patients with Non-Dialysis-Dependent CKD
Session Information
- CKD: Clinical, Outcomes, Trials - I
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Pergola, Pablo E., Renal Associates, P.A., San Antonio, Texas, United States
- Kopyt, Nelson P., Lehigh Valley Hospital, Bethlehem, Pennsylvania, United States
- Sampson, Mark R., Shield Therapeutics, Knebworth, United Kingdom
Background
Iron-deficiency anemia (IDA) is a major cause of morbidity/mortality in CKD. Ferric maltol (FM) is an oral iron replacement therapy formulated to improve absorption and reduce adverse events (AEs). FM significantly increased hemoglobin (Hb) and iron indices from baseline to week 16 vs placebo (PL) in a phase 3 trial in patients with stage 3/4 CKD (Kopyt ASN 2018). We present 52-week data from that trial.
Methods
Patients aged ≥18 years with stage 3/4 CKD and IDA [Hb 8.0–11.0 g/dL + either ferritin <250 μg/L with transferrin saturation (TSAT) <25% or ferritin <500 μg/L with TSAT <15%] were randomized 2:1 to oral FM 30 mg or PL twice daily for 16 weeks, followed by open-label (OL) FM for a further 36 weeks. Changes from baseline to Week 52 in Hb, ferritin, and TSAT were assessed in the intent-to-treat population.
Results
Of 167 patients randomized (FM 111, PL 56), 125 started open-label FM, and 92 completed 52 weeks. Improvements in Hb and iron indices with FM during double-blind treatment were maintained with OL FM to Week 52, while changes in Hb and iron indices for those moving from PL to FM mirrored the changes seen with FM during double-blind treatment (Figure). Drug-related AEs (mostly gastrointestinal) were recorded in 24 patients in the OL phase. Eleven patients discontinued treatment because of AEs during the OL phase.
Conclusion
Long-term treatment with FM was associated with sustained and clinically meaningful increases in Hb and iron indices, further confirming efficacy of oral FM for treating IDA in patients with stage 3/4 CKD. There were no new safety signals with up to 52 weeks’ treatment.
Funding
- Commercial Support – Shield Therapeutics plc