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

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.