- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968368
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease (AEGIS-CKD)
October 5, 2020 updated by: Shield Therapeutics
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
167
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Peoria, Arizona, United States
-
Phoenix, Arizona, United States
-
Prescott, Arizona, United States
-
Tucson, Arizona, United States
-
-
California
-
La Mesa, California, United States
-
Long Beach, California, United States
-
Roseville, California, United States
-
Sacramento, California, United States
-
-
Colorado
-
Denver, Colorado, United States
-
-
Florida
-
Coral Springs, Florida, United States
-
Edgewater, Florida, United States
-
Lauderdale Lakes, Florida, United States
-
Miami, Florida, United States
-
-
Georgia
-
Macon, Georgia, United States
-
-
Louisiana
-
Shreveport, Louisiana, United States
-
-
Michigan
-
Pontiac, Michigan, United States
-
Roseville, Michigan, United States
-
-
Nevada
-
Las Vegas, Nevada, United States
-
-
North Carolina
-
Asheville, North Carolina, United States
-
Charlotte, North Carolina, United States
-
Wilmington, North Carolina, United States
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States
-
-
Tennessee
-
Knoxville, Tennessee, United States
-
Nashville, Tennessee, United States
-
-
Texas
-
El Paso, Texas, United States
-
San Antonio, Texas, United States
-
-
Virginia
-
Hampton, Virginia, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral ferric maltol
30mg capsules BID
|
Other Names:
|
Placebo Comparator: Oral placebo
Matching placebo capsules BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hb Concentration From Baseline to Week 16
Time Frame: 16 weeks
|
Change in hemoglobin concentration from baseline to Week 16.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 an increase in Hemoglobin concentration of ≥1 g/dL at Week 16
|
16 weeks
|
Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
Time Frame: 16 weeks
|
Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16
|
16 weeks
|
Change in Hb Concentration From Baseline to Week 8
Time Frame: 8 weeks
|
Change in Hemoglobin concentration from baseline to Week 8
|
8 weeks
|
Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
Time Frame: 16 weeks
|
Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16
|
16 weeks
|
Changes in Ferritin From Baseline to Week 16
Time Frame: baseline to week 16
|
Changes in iron parameter - ferritin - from baseline to week 16
|
baseline to week 16
|
Number of Participants With (TEAEs)
Time Frame: Week 16
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
|
Week 16
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Week 16
|
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase
|
Week 16
|
Changes in TSAT From Baseline to Week 16
Time Frame: baseline to week 16
|
Changes in iron parameters - TSAT - from baseline to week 16
|
baseline to week 16
|
Changes in Iron Parameter From Baseline to Week 16
Time Frame: from baseline to week 16
|
Changes in iron parameters - serum iron - from baseline to week 16
|
from baseline to week 16
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Week 52
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase
|
Week 52
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Week 52
|
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase
|
Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark Sampson, MBChB, Shield Therapeutics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
January 18, 2018
Study Completion (Actual)
October 10, 2018
Study Registration Dates
First Submitted
August 30, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimate)
November 18, 2016
Study Record Updates
Last Update Posted (Actual)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 5, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST10-01-303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Insufficiency, Chronic
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
University of PennsylvaniaTeleflex; Arrow InternationalCompletedRenal Failure Chronic Requiring Hemodialysis | Chronic Renal InsufficiencyUnited States
-
Hospices Civils de LyonCompletedChronic Renal Insufficiency | Cardiac TransplantationFrance
-
CHU de ReimsUnknownChronic Renal InsufficiencyFrance
-
Southern Medical University, ChinaTerminatedChronic Kidney Failure
-
Centre Hospitalier Universitaire de NiceTerminatedAged | Chronic Renal Insufficiency | Chronic Kidney FailureFrance
-
Azienda Sanitaria ASL Avellino 2UnknownChronic Renal InsufficiencyItaly
-
Assistance Publique Hopitaux De MarseilleCompletedChronic Renal InsufficiencyFrance
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States