NCT02968368: AEGIS-CKD

Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

Completed Phase 3 Results posted Last updated 2 November 2020

What this trial tests

Phase 3 trial testing Ferric maltol in Renal Insufficiency, Chronic in 167 participants. Completed in 10 October 2018.

Timeline

1 December 2016

Primary endpoint
18 January 2018

10 October 2018

Quick facts

Lead sponsor	Shield Therapeutics
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	167
Start date	1 December 2016
Primary completion	18 January 2018
Estimated completion	10 October 2018
Sites	27 locations across United States

Drugs / interventions tested

• Ferric maltol (FERRIC MALTOL) — full drug profile →
• Placebo

Conditions studied

• Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →
• Iron-Deficiency Anemia — all drugs for Iron-Deficiency Anemia →

Sponsor

Shield Therapeutics — full company profile →

Who can join

18 and older, any sex, with Renal Insufficiency, Chronic or Iron-Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hb Concentration From Baseline to Week 16 Primary · 16 weeks

Change in hemoglobin concentration from baseline to Week 16.

Group	Value	95% CI
Oral Ferric Maltol	0.50	± 0.122
Oral Placebo	-0.02	± 0.165

Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16 Secondary · 16 weeks

Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16

Group	Value	95% CI
Oral Ferric Maltol	22
Oral Placebo	5

Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16 Secondary · 16 weeks

Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16

Group	Value	95% CI
Oral Ferric Maltol	30
Oral Placebo	7

Change in Hb Concentration From Baseline to Week 8 Secondary · 8 weeks

Change in Hemoglobin concentration from baseline to Week 8

Group	Value	95% CI
Oral Ferric Maltol	0.53	± 0.901
Oral Placebo	0.00	± 0.909

Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16 Secondary · 16 weeks

Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16

Group	Value	95% CI
Oral Ferric Maltol	7
Oral Placebo	0

Changes in Ferritin From Baseline to Week 16 Secondary · baseline to week 16

Changes in iron parameter - ferritin - from baseline to week 16

Group	Value	95% CI
Oral Ferric Maltol	33.13	± 6.166
Oral Placebo	-5.90	± 9.137

Number of Participants With (TEAEs) Secondary · Week 16

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Group	Value	95% CI
Oral Ferric Maltol	75
Oral Placebo	42

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Secondary · Week 16

Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase

Group	Value	95% CI
Oral Ferric Maltol	23
Oral Placebo	12

Changes in TSAT From Baseline to Week 16 Secondary · baseline to week 16

Changes in iron parameters - TSAT - from baseline to week 16

Group	Value	95% CI
Oral Ferric Maltol	4.32	± 0.719
Oral Placebo	-0.15	± 1.060

Changes in Iron Parameter From Baseline to Week 16 Secondary · from baseline to week 16

Changes in iron parameters - serum iron - from baseline to week 16

Group	Value	95% CI
Oral Ferric Maltol	1.87	± 0.397
Oral Placebo	0.01	± 0.586

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · Week 52

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase

Group	Value	95% CI
Oral Ferric Maltol	76
Oral Placebo	35

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Secondary · Week 52

Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase

Group	Value	95% CI
Oral Ferric Maltol	27
Oral Placebo	9

Adverse events — posted to ClinicalTrials.gov

Time frame: 16 week double blind phase. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Ferric Maltol DB

Serious: 23/111 (21%)

Deaths: 75/111

Oral Placebo DB

Serious: 12/56 (21%)

Deaths: 42/56

Oral Ferric Maltol OL

Serious: 27/86 (31%)

Deaths: 76/86

Oral Placebo OL

Serious: 9/39 (23%)

Deaths: 35/39

Serious adverse events (69 terms)

Reaction	System	Oral Ferric Maltol DB	Oral Placebo DB	Oral Ferric Maltol OL	Oral Placebo OL
Anemia	Blood and lymphatic system disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Sudden death	General disorders	—	—	—	—
Hemorrhagic anemia	Blood and lymphatic system disorders	—	—	—	—
Iron deficiency anemia	Blood and lymphatic system disorders	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—
Atrioventricular block complete	Cardiac disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—	—	—
Fluid overload	Metabolism and nutrition disorders	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—	—
Diverticulum intestinal	Gastrointestinal disorders	—	—	—	—
Duodenal polyp	Gastrointestinal disorders	—	—	—	—
Gastritis erosive	Gastrointestinal disorders	—	—	—	—
Gastrointestinal hemorrhage	Gastrointestinal disorders	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—

Other adverse events (27 terms — click to expand)

Reaction	System	Oral Ferric Maltol DB	Oral Placebo DB	Oral Ferric Maltol OL	Oral Placebo OL
Gastrointestinal disorders	Gastrointestinal disorders	—	—	—	—
Infections and infestations	Infections and infestations	—	—	—	—
Metabolism and nutrition disorders	Metabolism and nutrition disorders	—	—	—	—
Respiratory, thoracic, and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Injury, poisoning, and procedural complications	Injury, poisoning and procedural complications	—	—	—	—
General disorders and administration site conditions	General disorders	—	—	—	—
Vascular disorders	Vascular disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Renal and urinary disorders	Renal and urinary disorders	—	—	—	—
Blood and lymphatic system disorders	Blood and lymphatic system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Feces discolored	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Edema peripheral	General disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Most-reported serious reactions: Anemia, Cardiac failure congestive, Pneumonia, Urinary tract infection, Acute kidney injury, Sudden death, Hemorrhagic anemia, Iron deficiency anemia.

Data from ClinicalTrials.gov NCT02968368 adverse events section.

Sponsor's own description

To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment of Iron Deficiency Anemia in CKD and End-Stage Kidney Disease.
   Gutiérrez OM. · · 2021 · cited 44× · PMID 34514189 · DOI 10.1016/j.ekir.2021.05.020
2. Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension.
   Pergola PE, Kopyt NP. · · 2021 · cited 26× · PMID 34029682 · DOI 10.1053/j.ajkd.2021.03.020
3. Identification of Common Data Elements from Pivotal FDA Trials.
   Mayer CS, Williams N, Huser V. · · 2020 · cited 2× · PMID 33936456