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Abstract: PO0254

Long-Term Use of Ferric Citrate in the Treatment of Iron Deficiency Anemia in Patients with Non-Dialysis-Dependent CKD: The COMPASS Trial

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Belo, Diogo S., California Institute of Renal Research, Chula Vista, California, United States
  • Crawford, Paul W., Research by Design, Chicago, Illinois, United States
  • Moustafa, Moustafa A., South Carolina Nephrology & Hypertension Center, Inc, Orangeburg, South Carolina, United States
  • Luo, Wenli, Akebia Therapeutics, Inc., Cambridge, Massachusetts, United States
  • Goldfarb, Alex, Akebia Therapeutics, Inc., Cambridge, Massachusetts, United States
Background

Ferric citrate (FC) is an FDA-approved oral iron replacement for adults with iron deficiency anemia (IDA) and non–dialysis-dependent (NDD) CKD and as a phosphate binder in adults with dialysis-dependent CKD. For IDA, the recommended FC starting dose is 1 tablet (1 g, contains 210 mg ferric iron) 3 times daily (TID) titrated to maintain hemoglobin (Hb) goal. We studied the long-term efficacy and safety of various FC regimens for IDA treatment in adults with NDD-CKD (stages 3-5).

Methods

48-wk, phase 4, randomized, open-label, multicenter study (NCT03236246). Patients received (1:1) FC 1 g tablet TID (3 g/day) or 2 tablets BID (4 g/day). At Wk 12, if Hb was <10 g/dL or changed <0.5 g/dL from baseline (BL), dose was increased to 2 tablets TID (from 1 TID) or 3 tablets BID (from 2 BID). Primary endpoint was change in Hb from BL to Wk 24. Secondary endpoints included change in transferrin saturation (TSAT), ferritin, and phosphate to Wk 48.

Results

This analysis included 183 of 206 randomized patients. Groups were well matched, with mean age 69.5±10.3 y and 54% with CKD due to diabetes. Mean BL eGFR was 33.6±10.9 mL/min/1.73 m2, and Hb was 10.45±0.74 g/dL. Efficacy measures at 48 wks are presented in the Table. Adverse events (AEs) occurring in ≥5% included diarrhea (13.2%), discolored stool (12.7%), and constipation (12.2%). Incidence of serious AEs was 13.9% in BID and 17.3% in TID groups. Five deaths were reported, none deemed FC related by investigators.

Conclusion

Both FC regimens studied increased and maintained Hb through 48 wks in patients with NDD-CKD with IDA. Patients with lower baseline Hb and iron parameters had a higher increase in Hb with FC treatment. Serum phosphate remained within normal range over study duration. Mean changes in Hb, TSAT, ferritin, and phosphate were similar in the BID and TID and the 3 and 4 g/day dosing groups. These results support the potential for FC dosing flexibility in the long-term treatment of IDA.

Changes from baseline in efficacy variables after 48 wks of FC dosing

Funding

  • Commercial Support –