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Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease (AEGIS-CKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968368
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : May 1, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Shield Therapeutics

Tracking Information
First Submitted Date  ICMJE August 30, 2016
First Posted Date  ICMJE November 18, 2016
Results First Submitted Date  ICMJE November 19, 2019
Results First Posted Date  ICMJE May 1, 2020
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date January 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
Change in Hb Concentration From Baseline to Week 16 [ Time Frame: 16 weeks ]
Change in hemoglobin concentration from baseline to Week 16.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
Efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD [ Time Frame: 16 weeks ]
Change in Hb concentration from baseline to Week 16
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • 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
  • 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
  • Change in Hb Concentration From Baseline to Week 8 [ Time Frame: 8 weeks ]
    Change in Hemoglobin concentration from baseline to Week 8
  • 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
  • Changes in Ferritin From Baseline to Week 16 [ Time Frame: baseline to week 16 ]
    Changes in iron parameter - ferritin - from baseline to week 16
  • Number of Participants With (TEAEs) [ Time Frame: Week 16 ]
    Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
  • 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
  • Changes in TSAT From Baseline to Week 16 [ Time Frame: baseline to week 16 ]
    Changes in iron parameters - TSAT - from 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
Official Title  ICMJE 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
Brief Summary To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Insufficiency, Chronic
  • Iron-Deficiency Anemia
Intervention  ICMJE
  • Drug: Ferric maltol
    Other Name: Feraccru
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Oral ferric maltol
    30mg capsules BID
    Intervention: Drug: Ferric maltol
  • Placebo Comparator: Oral placebo
    Matching placebo capsules BID
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2020)
167
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)
168
Actual Study Completion Date  ICMJE October 10, 2018
Actual Primary Completion Date January 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Willing and able to comply with study requirements.
  3. Age ≥ 18 years at the time of informed consent.
  4. 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.
  5. Iron deficiency anemia defined by the following criteria assessed via screening laboratory results:

    1. Hb <11.0g/dL and ≥8.0g/dL
    2. AND ferritin <250ng/mL with a Transferrin saturation (TSAT) <25% OR ferritin <500ng/mL with a TSAT of <15%
  6. 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:

  1. Anemia due to any cause other than iron deficiency, including, but not limited to:

    1. Untreated or untreatable severe malabsorption syndrome.
    2. 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).
  2. Administration with any of the following prior to randomization:

    1. IV iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within the previous 12 weeks.
    2. 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.
    3. Use if ferric citrate and sucroferric oxyhydroxide within the previous 1 week.
    4. ESAs within the previous 4 weeks
    5. Blood transfusion or donation within the previous 12 weeks.
    6. Dimercaprol or cloramphenicol within the previous 7 days.
    7. Current use of methyldopa.
  3. Currently receiving dialysis or initiation of dialysis is considered likely during the study.
  4. Renal transplant within 12 months prior to randomization or is considered likely during the study.
  5. Known hypersensitivity or allergy to the active substance or excipients of ferric maltol or placebo capsules.
  6. Contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anemia, thalassemia, or lead intoxication induced anemia.
  7. 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.
  8. 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).
  9. Pregnant or breast feeding.
  10. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anemia; for example coagulation disorders or recurrent GI bleeding.
  11. 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).
  12. Participation in any other interventional clinical study within 30 days prior to screening.
  13. 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.
  14. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02968368
Other Study ID Numbers  ICMJE ST10-01-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shield Therapeutics
Study Sponsor  ICMJE Shield Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Sampson, MBChB Shield Therapeutics
PRS Account Shield Therapeutics
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP