Tags

Type your tag names separated by a space and hit enter

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 12; 78(6):846-856.e1.AJ

Abstract

RATIONALE & OBJECTIVE

Iron-deficiency anemia is common in patients with chronic kidney disease (CKD) not requiring kidney replacement therapy (KRT). We evaluated effects of oral iron replacement therapy with ferric maltol in these patients.

STUDY DESIGN

Phase 3, double-blind, randomized, placebo-controlled trial (AEGIS-CKD) and open-label extension.

SETTING & PARTICIPANTS

Adults with stage 3 or 4 CKD and iron-deficiency anemia at 30 US centers.

INTERVENTION

Oral ferric maltol at 30mg or placebo twice daily for 16 weeks (2:1 randomization) followed by ferric maltol at 30mg twice daily for up to 36 weeks (all patients).

OUTCOME

Change from baseline in hemoglobin (primary end point at week 16), ferritin, transferrin saturation, and serum iron; safety.

RESULTS

167 patients were randomized (ferric maltol, n=111; placebo, n=56). At week 16, hemoglobin had increased significantly with ferric maltol versus placebo (least-squares mean difference: 0.5±0.2 [SE] g/dL; 95% CI, 0.1-0.9; P=0.01). Ferritin, transferrin saturation, and serum iron increased with ferric maltol but declined with placebo (all P<0.05). Hemoglobin levels were sustained up to week 52 in patients continuing ferric maltol and increased in patients switching from placebo to ferric maltol. The most frequent adverse events were gastrointestinal (randomized phase: 41% vs 30% [ferric maltol vs placebo]; open-label phase: 56% vs 46%, respectively). Adverse events led to treatment withdrawal in 7 patients (6%) receiving ferric maltol and 5 patients (9%) receiving placebo during double-blind treatment, and 11 patients (9%) during the open-label extension.

LIMITATIONS

Heterogeneity in baseline ferritin levels; high proportion of female participants; single-arm open-label extension.

CONCLUSIONS

Ferric maltol was associated with statistically significant (week 16) and sustained (up to week 52) increases in hemoglobin and iron indices in patients with CKD and iron deficiency, and was well tolerated during treatment for up to 52 weeks.

FUNDING

Funded by Shield Therapeutics (UK) Ltd.

TRIAL REGISTRATION

Registered at ClinicalTrials.gov with study number NCT02968368.

Authors+Show Affiliations

Renal Associates PA, San Antonio, TX.Division of Nephrology, Department of Medicine, Lehigh Valley Hospital, Allentown, PA. Electronic address: nkopyt@gmail.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

34029682

Citation

Pergola, Pablo E., and Nelson P. Kopyt. "Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: a Randomized Trial and Open-Label Extension." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 78, no. 6, 2021, pp. 846-856.e1.
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;78(6):846-856.e1.
Pergola, P. E., & Kopyt, N. P. (2021). Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 78(6), 846-e1. https://doi.org/10.1053/j.ajkd.2021.03.020
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;78(6):846-856.e1. PubMed PMID: 34029682.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. AU - Pergola,Pablo E, AU - Kopyt,Nelson P, Y1 - 2021/05/23/ PY - 2020/11/11/received PY - 2021/03/05/accepted PY - 2021/5/25/pubmed PY - 2022/1/18/medline PY - 2021/5/24/entrez KW - Anemia KW - Ferritin KW - chronic kidney disease (CKD) KW - ferric maltol KW - hemoglobin KW - iron deficiency KW - long term KW - oral iron KW - randomized controlled trial (RCT) KW - tolerability KW - transferrin saturation SP - 846 EP - 856.e1 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 78 IS - 6 N2 - RATIONALE & OBJECTIVE: Iron-deficiency anemia is common in patients with chronic kidney disease (CKD) not requiring kidney replacement therapy (KRT). We evaluated effects of oral iron replacement therapy with ferric maltol in these patients. STUDY DESIGN: Phase 3, double-blind, randomized, placebo-controlled trial (AEGIS-CKD) and open-label extension. SETTING & PARTICIPANTS: Adults with stage 3 or 4 CKD and iron-deficiency anemia at 30 US centers. INTERVENTION: Oral ferric maltol at 30mg or placebo twice daily for 16 weeks (2:1 randomization) followed by ferric maltol at 30mg twice daily for up to 36 weeks (all patients). OUTCOME: Change from baseline in hemoglobin (primary end point at week 16), ferritin, transferrin saturation, and serum iron; safety. RESULTS: 167 patients were randomized (ferric maltol, n=111; placebo, n=56). At week 16, hemoglobin had increased significantly with ferric maltol versus placebo (least-squares mean difference: 0.5±0.2 [SE] g/dL; 95% CI, 0.1-0.9; P=0.01). Ferritin, transferrin saturation, and serum iron increased with ferric maltol but declined with placebo (all P<0.05). Hemoglobin levels were sustained up to week 52 in patients continuing ferric maltol and increased in patients switching from placebo to ferric maltol. The most frequent adverse events were gastrointestinal (randomized phase: 41% vs 30% [ferric maltol vs placebo]; open-label phase: 56% vs 46%, respectively). Adverse events led to treatment withdrawal in 7 patients (6%) receiving ferric maltol and 5 patients (9%) receiving placebo during double-blind treatment, and 11 patients (9%) during the open-label extension. LIMITATIONS: Heterogeneity in baseline ferritin levels; high proportion of female participants; single-arm open-label extension. CONCLUSIONS: Ferric maltol was associated with statistically significant (week 16) and sustained (up to week 52) increases in hemoglobin and iron indices in patients with CKD and iron deficiency, and was well tolerated during treatment for up to 52 weeks. FUNDING: Funded by Shield Therapeutics (UK) Ltd. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02968368. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/34029682/Oral_Ferric_Maltol_for_the_Treatment_of_Iron_Deficiency_Anemia_in_Patients_With_CKD:_A_Randomized_Trial_and_Open_Label_Extension_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(21)00624-7 DB - PRIME DP - Unbound Medicine ER -