Renal Insufficiency, ChronicPhase 3AEGIS-CKDNCT02968368

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

A Phase 3 study testing Ferric maltol in people with Renal Insufficiency, Chronic and Iron-Deficiency Anemia, run by Shield Therapeutics at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Insufficiency, Chronic, Iron-Deficiency Anemia
What is being tested?: Ferric maltol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 167 participants
Where: 27 sitesUnited States
Study dates: 1 Dec 2016to 10 Oct 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form. Must sign and date the informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure.
Willing and able to comply with study requirements.
Age ≥ 18 years at the time of informed consent.
A current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2, as calculated using the abbreviated version of the Modified Diet in Renal Disease equation (MDRD) assessed via screening laboratory results.
Iron deficiency anemia defined by the following criteria assessed via screening laboratory results:
Hb <11.0g/dL and ≥8.0g/dL
AND ferritin <250ng/mL with a Transferrin saturation (TSAT) <25% OR ferritin <500ng/mL with a TSAT of <15%
Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive medications. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.

Who cannot join

Anemia due to any cause other than iron deficiency, including, but not limited to:
Untreated or untreatable severe malabsorption syndrome.
Myelosuppression use (permitted if taken at a stable dose and frequency for at least 12 weeks prior to randomization and are expected to stay stable throughout the double-blind treatment period so long as there is no clinical evidence of the myelosuppression contributing to the subject's anemia).
Administration with any of the following prior to randomization:
IV iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within the previous 12 weeks.
Single agent oral iron supplementation, taken specifically to treat anemia (e.g. ferrous sulfate, fumarate and gluconate) within the previous 2 weeks. Multivitamins are permitted.

Show all 23Show fewer

Use if ferric citrate and sucroferric oxyhydroxide within the previous 1 week.
ESAs within the previous 4 weeks
Blood transfusion or donation within the previous 12 weeks.
Dimercaprol or cloramphenicol within the previous 7 days.
Current use of methyldopa.
Currently receiving dialysis or initiation of dialysis is considered likely during the study.
Renal transplant within 12 months prior to randomization or is considered likely during the study.
Known hypersensitivity or allergy to the active substance or excipients of ferric maltol or placebo capsules.
Contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anemia, thalassemia, or lead intoxication induced anemia.
Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3 times the upper limit of normal as assessed via screening laboratory results.
Clinically significant vitamin B12 or folic acid deficiency as determined by the screening laboratory results (retest following at least 2 weeks of starting treatment with vitamin B12 or folate replacement is permitted).
Pregnant or breast feeding.
Concomitant medical conditions with significant active bleeding likely to initiate or prolong anemia; for example coagulation disorders or recurrent GI bleeding.
Scheduled or expected major surgery during the course of the study. (Minor surgeries not associated with significant blood loss, in the Investigator's judgement, are permitted e.g. surgery related to fistulae or vascular access, minor dental extractions, incision and drainage of abscess or simple excisions).
Participation in any other interventional clinical study within 30 days prior to screening.
Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject.
Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Study site
Asheville, North Carolina
Study site
Bethlehem, Pennsylvania
Study site
Charlotte, North Carolina
Study site
Coral Springs, Florida
Study site
Denver, Colorado
Study site
Edgewater, Florida
Study site
El Paso, Texas
Study site
Hampton, Virginia
Study site
Knoxville, Tennessee
Study site
La Mesa, California
Study site
Las Vegas, Nevada
Study site
Lauderdale Lakes, Florida
Study site
Long Beach, California
Study site
Macon, Georgia
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
Peoria, Arizona
Study site
Phoenix, Arizona
Study site
Pontiac, Michigan
Study site
Prescott, Arizona
Study site
Roseville, California
Study site
Roseville, Michigan
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
Shreveport, Louisiana
Study site
Tucson, Arizona
Study site
Wilmington, North Carolina

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

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

Conditions: Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Being tested: Ferric maltol, Placebo
Medical subject headings: Renal Insufficiency, Chronic, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric maltolDrug
Also called Feraccru
PlaceboOther

Study groups in NCT02968368
Study group	Role	What they receive
Oral ferric maltol	Experimental	30mg capsules BID Receives: Drug: Ferric maltol
Oral placebo	Placebo comparator	Matching placebo capsules BID Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hb Concentration From Baseline to Week 16
Change in hemoglobin concentration from baseline to Week 16.
Measured: 16 weeks

Secondary outcomes (11)

Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16
Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16
Measured: 16 weeks
Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16
Measured: 16 weeks
Change in Hb Concentration From Baseline to Week 8
Change in Hemoglobin concentration from baseline to Week 8
Measured: 8 weeks
Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16
Measured: 16 weeks
Changes in Ferritin From Baseline to Week 16
Changes in iron parameter - ferritin - from baseline to week 16
Measured: baseline to week 16
Number of Participants With (TEAEs)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Week 16
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase
Measured: Week 16
Changes in TSAT From Baseline to Week 16
Changes in iron parameters - TSAT - from baseline to week 16
Measured: baseline to week 16
Changes in Iron Parameter From Baseline to Week 16
Changes in iron parameters - serum iron - from baseline to week 16
Measured: from baseline to week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase
Measured: Week 52
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201610 Oct 2018

First posted18 Nov 2016 (estimated)
Study start1 Dec 2016
Primary completion18 Jan 2018
Study completion10 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02968368
Sponsor's protocol ID: ST10-01-303
Acronym: AEGIS-CKD
Status last verified: Oct 2020
First submitted: 30 Aug 2016
Last updated: 2 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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 Dec;78(6):846-856.e1. doi: 10.1053/j.ajkd.2021.03.020. Epub 2021 May 23.
PubMed 34029682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT02968368
Acronym / sponsor ID: AEGIS-CKD / ST10-01-303
Conditions: Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Shield TherapeuticsIndustry (pharma, biotech, devices)
Study start: 1 Dec 2016 (actual)
Primary completion: 18 Jan 2018 (actual)
Study completion: 10 Oct 2018 (actual)
First posted: 18 Nov 2016 (estimated)
Results: Posted 1 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oral ferric maltol	Experimental	Drug: Ferric maltol30mg capsules BID
Oral placebo	Placebo comparator	Other: PlaceboMatching placebo capsules BID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Ability to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form. Must sign and date the informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure.
Willing and able to comply with study requirements.
Age ≥ 18 years at the time of informed consent.
A current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2, as calculated using the abbreviated version of the Modified Diet in Renal Disease equation (MDRD) assessed via screening laboratory results.
Iron deficiency anemia defined by the following criteria assessed via screening laboratory results:

Key exclusion criteria (23 listed)

Anemia due to any cause other than iron deficiency, including, but not limited to:
Administration with any of the following prior to randomization:
Currently receiving dialysis or initiation of dialysis is considered likely during the study.
Renal transplant within 12 months prior to randomization or is considered likely during the study.
Known hypersensitivity or allergy to the active substance or excipients of ferric maltol or placebo capsules.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ferric maltolAlso: Feraccru	Drug	Oral ferric maltol
Placebo	Other	Oral placebo

Primary outcome

Change in Hb Concentration From Baseline to Week 16
Time frame: 16 weeks
Change in hemoglobin concentration from baseline to Week 16.

11 secondary outcomes

Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16
Time frame: 16 weeks
Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
Time frame: 16 weeks
Change in Hb Concentration From Baseline to Week 8
Time frame: 8 weeks
Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
Time frame: 16 weeks
Changes in Ferritin From Baseline to Week 16
Time frame: baseline to week 16
Number of Participants With (TEAEs)
Time frame: Week 16
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Week 16
Changes in TSAT From Baseline to Week 16
Time frame: baseline to week 16
Changes in Iron Parameter From Baseline to Week 16
Time frame: from baseline to week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Week 52
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Week 52

Results and safety

Results posted to the registry on 1 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Ferric Maltol	111	90
Oral Placebo	56	39

Primary outcome: Change in Hb Concentration From Baseline to Week 16

Time frame: 16 weeks. Least squares mean (Standard Deviation). Unit: g/dl

Measure	Oral Ferric Maltol n = 88	Oral Placebo n = 40
Value	0.50 (0.122)	-0.02 (0.165)

Oral Ferric Maltol vs Oral Placebo: Mean Difference (Final Values): 0.52 (95% CI 0.102 to 0.930), p = 0.0149, ANCOVA

Population analysed: ITT

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 week double blind phase. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Ferric Maltol DB	23 of 111 (20.7%)	75 of 111 (67.6%)	75 of 111
Oral Placebo DB	12 of 56 (21.4%)	42 of 56 (75%)	42 of 56
Oral Ferric Maltol OL	27 of 86 (31.4%)	76 of 86 (88.4%)	76 of 86
Oral Placebo OL	9 of 39 (23.1%)	35 of 39 (89.7%)	35 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34029682Pergola 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 Dec;78(6):846-856.e1. doi: 10.1053/j.ajkd.2021.03.020. Epub 2021 May 23.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Sampson, MBChB study director

Shield Therapeutics

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferric maltol in people with Renal Insufficiency, Chronic and Iron-Deficiency Anemia, run by Shield Therapeutics at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hb Concentration From Baseline to Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02968368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.