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

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ClinicalTrials.gov Identifier: NCT02968368
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Shield Therapeutics

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

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Iron-Deficiency Anemia Drug: Ferric maltol Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral ferric maltol
30mg capsules BID
Drug: Ferric maltol
Other Name: Feraccru

Placebo Comparator: Oral placebo
Matching placebo capsules BID
Other: Placebo



Primary Outcome Measures :
  1. Change in Hb concentration from baseline to Week 16 [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects that achieve an increase in Hb concentration of ≥1 g/dL at Week 16maltol in subjects with IDA and CKD over a treatment duration of up to 52 weeks [ Time Frame: 16 weeks ]
  2. Proportion of subjects that achieve a Hb concentration of ≥11 g/dL at week 16 [ Time Frame: 16 weeks ]
  3. Change in Hb concentration from baseline to Week 8 [ Time Frame: 8 weeks ]
  4. Proportion of subjects that achieve an increase in Hb concentration of ≥2 g/dL at Week 16 [ Time Frame: 16 weeks ]
  5. Changes in iron parameters (ferritin, TSAT, serum iron) [ Time Frame: Week 52 ]
  6. Treatment-emergent Adverse Events (AEs) [ Time Frame: Week 52 ]
  7. Treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: Week 52 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form and must sign and date the informed consent prior to any study mandated procedure.
  2. Subjects must be willing and able to comply with study requirements.
  3. Age ≥ 18 years.
  4. Subjects must have 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. Subjects must have iron deficiency anemia defined by the following criteria assessed via Screening laboratory results:

    1. Hb <11.0 and >8.0g/dl
    2. AND Ferritin <250 ng/ml
    3. AND Transferrin saturation (TSAT) <25%
  6. Subjects using ESA agents must have been on a stable dose for at least 8 weeks prior to randomization (i.e no greater than 20% change in weekly dose).
  7. Female subject 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, or a vasectomized partner. Oral contraceptive medications are allowed in this study. 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. Subject with 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 for at least 3 months prior to Randomization and are expected to stay stable throughout the study treatment period so long as there is no clinical evidence or suspicion of the myelosuppression contributing to the subject's anemia).
  2. Subject who has received any of the following prior to Randomization:

    1. Intravenous (IV) iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within previous 12 weeks.
    2. Oral iron supplementation, taken specifically to treat anemia within the previous 2 weeks (multivitamins containing iron are permitted).
    3. Blood transfusion or donation within the previous 12 weeks.
  3. Subject for whom the initiation of dialysis or renal transplant is considered likely during the study.
  4. Subject who received a renal transplant within 12 months prior to Randomization.
  5. Subject with known hypersensitivity or allergy to the active substance or excipients of ferric maltol capsules.
  6. Subject with 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. Subjects with clinically significant vitamin B12 or folic acid deficiency as determined by the Screening laboratory results (rescreen following at least 2 weeks of starting treatment with vitamin B12 or folate replacement is permitted).
  9. Subjects who are 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. Subject with scheduled or expected hospitalization and/or surgery during the course of the study; with the exception of surgery related to fistulae or vascular access.
  12. Participation in any other interventional clinical study within 30 days prior to Screening.
  13. Subject with 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968368


Contacts
Contact: Mark R Sampson, MBChB +44 7733 304886 msampson@shieldtherapeutics.com
Contact: Aleksandar Sarac, MPharm asarac@shieldtherapeutics.com

  Show 27 Study Locations
Sponsors and Collaborators
Shield Therapeutics
Investigators
Study Director: Mark Sampson, MBChB Shield Therapeutics

Responsible Party: Shield Therapeutics
ClinicalTrials.gov Identifier: NCT02968368     History of Changes
Other Study ID Numbers: ST10-01-303
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Ferric Compounds
Hematinics