Kidney Week

Abstract: FR-OR120

Efficacy and Safety of Oral Ferric Maltol (FM) in Treating Iron-Deficiency Anemia (IDA) in Patients with CKD: Randomized Controlled Trial

Session Information

• Towards Better Medication Usage in Patients with CKD
  October 26, 2018 | Location: 26A, San Diego Convention Center
  Abstract Time: 06:06 PM - 06:18 PM

Category: Anemia and Iron Metabolism

• 202 Anemia and Iron Metabolism: Clinical

Author

• Kopyt, Nelson P., Lehigh Valley Hospital, Allentown, Pennsylvania, United States

Nelson P. Kopyt, DO



Nelson P. Kopyt, DO, FASN, FACP, CPI (Certified Physician Investigator) is a Clinical Professor of Medicine at Morsani College of Medicine, Allentown, Pennsylvania, Chief of Nephrology at the Lehigh Valley Hospital in Allentown, Pennsylvania and Medical Director and Director of Research at the Northeast Clinical Research Center, Allentown, Pennsylvania. He received his medical training at the Philadelphia College of Osteopathic Medicine and his postdoctoral training in nephrology and internal medicine at Temple University Hospital in Philadelphia. He currently practices at Valley Kidney Specialists, Allentown, Pennsylvania.

Group or Team Name

• AEGIS-CKD Study Group

Background

IDA is common in CKD and is a leading cause of morbidity and mortality. Oral ferrous products for IDA may be poorly tolerated due to gastrointestinal (GI) adverse events (AEs). Intravenous iron can be inconvenient and has the risk of allergic reactions or iron overload. Patients with CKD and IDA would benefit from effective, well tolerated oral iron replacement therapy. FM is an oral iron replacement therapy for IDA formulated to improve GI absorption. A phase 3 multicenter double-blind, randomized controlled trial (NCT02968368) evaluated the efficacy and safety of FM in patients with stage 3/4 CKD.

Methods

Patients aged ≥18 years with CKD (estimated GFR ≥15 to <60 mL/min/1.73 m²) and IDA (hemoglobin [Hb] ≥8.0 to <11.0 g/dL, and 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 placebo twice daily for 16 weeks. The primary endpoint was change in Hb from baseline to Week 16 using analysis of covariance of the intent-to-treat population. Also reported are data on all iron parameters measured in the trial; changes from baseline in ferritin, TSAT, and serum iron were assessed at Weeks 4, 8, and 16.

Results

Of 167 patients randomized (FM 111, placebo 56), 77% completed double-blind treatment (FM 81%, placebo 70%). All iron parameters were significantly improved with FM vs placebo over 16 weeks (Table).
GI disorders were the most common drug-related AEs (FM 18%, placebo 7%). Serious AEs occurred in 21% in each group; none was considered to be study-drug related. Two patients died (one in each group), both considered unrelated to study drug.

Conclusion

FM resulted in statistically significant and clinically meaningful increases in Hb concentration and all iron parameters from baseline to week 16 vs placebo, supporting the efficacy of oral FM in treating IDA in patients with stage 3 or 4 CKD. FM was generally well tolerated, with only minor differences in the safety profile and overall GI AEs vs placebo.

Least-square mean change from baseline to Week 16

Funding

• Commercial Support – Shield Therapeutics Ltd