Chronic Kidney Disease

Fatigue and declining kidney function can persist when iron deficiency (ID) and iron deficiency anemia (IDA) go untreated.49,51

Prevalence of ID and IDA

Up to 85% of patients with chronic kidney disease (CKD) are iron deficient.49 

Chronic inflammation and impaired absorption make long-term iron repletion especially challenging for this patient population and limit the effectiveness of traditional oral iron. Ferrous salts often dissociate in the stomach, leading to upwards of 90% of iron going unabsorbed.6,33,49

The Patient

Hispanic man in front of a yellow background

*Not actual patient.

Anthony*

62-year-old Hispanic male with stage 3 CKD, hypertension, hyperlipidemia, diabetes, and ID

Lab Markers Anthony's Labs

Hb

10.5 g/dL

Ferritin

 35 μg/L

TSAT

16.4%

eGFR

45mL/min/1.73m2

Common complaints: 

  • Fatigue
  • Weakness
  • Pale skin
  • Cold intolerance


Pertinent medical history and medication list: 

  • Angiotensin converting enzyme (ACE) inhibitor and water pill for hypertension
  • Statin for hyperlipidemia
  • Insulin for diabetes
Hispanic man in front of a yellow background

*Not actual patient.

Chronic Kidney Disease (CKD)

Up to 85% of patients with CKD are iron deficient.49Testing if I can do two lines:

ACCRUFeR Placebo Endpoint

+0.50 (0.12) 

Baseline (BL): 10.1 (0.77)

-0.02 (0.16) 

BL: 10.0 (0.82)

Hb g/dL 

LS mean (SE) change at Week 16

+3.8 (0.6) 

BL: 15.7 (6.4)

-0.9 (0.9) BL: 15.6 (5.9)

Secondary: TSAT % LS mean (SE) change at Week 16

Study Description

  • 16-week, pivotal Phase 3 trial
  • 167 adults with IDA and Stage 3 or 4 CKD
  • Excluded patients taking erythropoiesis-stimulating agents

The ACCRUFeR Difference

ACCRUFeR® (ferric maltol) established safety and efficacy treating ID/IDA in adults with stage 3 or 4 CKD, excluding those on erythropoiesis-stimulating agents, in a 16-week, phase 3A, randomized and placebo-controlled pivotal trial with a 36-week open label extension phase.2,6

In clinical studies, ACCRUFeR demonstrated:

  • Significant Hb Improvement: A 52 g/dL LS mean improvement in Hb compared to placebo (95% CI: 0.10, 0.93; P=0.0149) in week 16.2
  • Increase in TSAT: 3.8 (0.6) mean percentage change in TSAT from baseline (LS mean, SE) to Week 16 in compared to -0.9 (0.9) for the placebo group.2,6
  • Rapid Absorption: Total serum iron peak values were reached 1.5 to 3 hours after administration of ACCRUFeR and were comparable between Day 1 and Day 8.2
  • Tolerability: 4.6% of patients (n=175) discontinued ACCRUFeR because of adverse reactions compared to 2.5% of patients (n=120) on placebo.*,2

*Adverse reactions that were reported by ≥1% of patients treated with ACCRUFeR during double-blind phases of the placebo-controlled period of pooled pivotal studies (AEGIS IBD and AEGIS CKD)

More about ACCRUFeR's clinical studies

About ACCRUFeR

See how ACCRUFeR's MALTOL SHIELDTM helps minimize the risk of gastrointestinal side effects.2-4

Established Safety and Efficacy

ACCRUFeR is backed by a robust clinical profile. It has demonstrated both short- and long-term efficacy across three pivotal clinical studies.

References:
1. Schmidt C, Ahmad T, Tulassay Z, et al. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a phase 3 study. Aliment Pharmacol Ther. 2016;44(3):259-270. doi:10.1111/apt.13665

2. ACCRUFeR® full prescribing information. Shield Therapeutics, 2025.
3. Stallmach A, Büning C. Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-2867. doi:10.1517/14656566.2015.1096929
4. European Medicines Agency. Accessed March 17, 2021. https://www.ema.europa.eu/en/documents/variation-report/feraccru-h-c-2733-ii-0010-epar-assessment-report-variation_en.pdf
5. Gasche C, Ahmad T, Tulassay Z, et al. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015;21(3):579-588. doi:10.1097/mib.0000000000000314
6. 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.el. doi:10.1053/j.ajkd.2021.03.020
33. Howaldt S, Domènech E, Martinez N, Schmidt C, Bokemeyer B. Long-term effectiveness of oral ferric maltol vs intravenous ferric carboxymaltose for the treatment of iron-deficiency anemia in patients with inflammatory bowel disease: A randomized controlled noninferiority trial. Inflamm Bowel Dis. 2021;28(3):373-384. doi:10.1093/ibd/izab073.
49. Cappellini MD, Comin-Colet J, de Francisco A, et al. IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068- 1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7. PMID: 28612425; PMCID: PMC5599965.
51. Olsson K, Fuge J, Brod T, et al. Oral iron supplementation with ferric maltol in patients with pulmonary hypertension. Eur Respir J. Nov 2020. 12;56(5): 2000616.