Oral iron drug improves hemoglobin levels by week 16 for patients with CKD, anemia
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Patients with chronic kidney disease and iron-deficiency anemia saw statistically significant increases in hemoglobin levels following treatment with oral ferric maltol, according to data from a phase 3 randomized placebo-controlled trial.
Improvements in hemoglobin occurred by week 16 and were sustained up to week 52, results suggested.
“Our study involved 167 adults at 30 U.S. centers with moderate to severe CKD and anemia due to low blood iron levels,” Pablo E. Pergola, MD, PhD, of Renal Associates PA in San Antonio, and colleagues wrote of the study design. “They were split into two groups, one of which was given the drug, ferric maltol, and the other received a placebo; both groups took their capsules twice daily for 16 weeks. After that, participants were all given ferric maltol for another 36 weeks, so that we could look at the long-term effects of treatment.”
Double-blind treatment results
At week 16, 20% of individuals randomized to ferric maltol had a hemoglobin increase of at least 1 g per dL, with the treatment leading to a mean change in hemoglobin of 0.6 g per dL (27% had hemoglobin concentrations of at least 11 g per dL by week 16). For comparison, 9% of those who took placebo saw hemoglobin levels increase by 1 g per dL, with a mean change from baseline of -0.1 g per dL (13% had hemoglobin concentrations of at least 11 g per dL).
Treatment with ferric maltol also appeared to improve ferritin, TSAT and serum iron values; these measures declined in participants who took placebo.
“Patients with stage 3 CKD may experience a greater treatment effect than those with stage 4 disease, whereas patients with lower ferritin levels at baseline appear to be more likely to benefit than those with higher levels, although the low number of patients with ferritin levels above 250 ng/mL makes this finding difficult to interpret,” Pergola and colleagues wrote.
Open-label extension results
For patients initially randomized to treatment with ferric maltol, improvements in hemoglobin levels continued through week 52, with a total increase of 0.7 g per dL from baseline. Patients who were switched from placebo to ferric maltol experienced similar improvements in hemoglobin, with a total increase of 0.5 g per dL by the conclusion of the study period.
Regarding tolerability of the drug, researchers suggested adverse events were “manageable,” with gastrointestinal issues found to be most common. Withdrawal of ferric maltol occurred in seven patients. Two of these cases, which both involved nausea and vomiting, were determined to be drug related.
“[This] trial shows that oral ferric maltol raises and sustains hemoglobin to provide iron for erythropoiesis in patients with eGFR as low as 30 mL/min/1.73 m2 ; even in those with more severe CKD and a higher contribution of erythropoietin insufficiency, there may still be a benefit,” Pergola and colleagues concluded of the findings. “Further, ferric maltol provides significant and sustained increases in iron storage indices, providing long-term control of [iron-deficiency anemia] IDA.”
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