KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: ferric citrate; Placebo
Intervention description: 1 g ferric citrate containing approximately 210 mg of ferric iron; Matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ferric citrate; Chronic kidney disease; Anemia

Summary:

      a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized,
      double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week
      open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate)
      ("Extension Period").
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and non-lactating women with negative serum pregnancy test (for women of
             child-bearing potential) at Screening

          2. Age ≥18 years

          3. CKD with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min at Screening using the
             4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up
             to 20% of the target randomization of 230 subjects with eGFR <15 mL/min)

          4. Patients who were intolerant of or have had an inadequate therapeutic response to oral
             iron supplements (in the opinion of the investigator)

          5. Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening

          6. Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening

          7. Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening

          8. Must consume a minimum of 2 meals per day

          9. Willing and able to give written informed consent

        Exclusion Criteria:

          1. Serum phosphate <3.5 mg/dL at Screening

          2. Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening

          3. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks
             prior to Screening

          4. Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to
             Screening

          5. Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of
             Screening

          6. IV iron administered within 4 weeks prior to Screening

          7. Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening

          8. Blood transfusion within 4 weeks prior to Screening

          9. Receipt of any investigational drug within 4 weeks prior to Screening

         10. Cause of anemia other than iron deficiency or chronic kidney disease

         11. Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after
             curative therapy)

         12. History of hemochromatosis

         13. Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal
             marijuana) within the 12 months prior to Screening or evidence of such abuse (in the
             opinion of the PI)

         14. Subjects with known allergic reaction to previous oral iron therapy

         15. Previous intolerance to oral ferric citrate

         16. Psychiatric disorder that interferes with the subject's ability to comply with the
             study protocol

         17. Planned surgery or hospitalization (anticipated to last >72 hours) during the
             randomized period of the trial other than dialysis access related surgery.

         18. Any other medical condition that, in the opinion of the PI, renders the subject unable
             to or unlikely to complete the trial or that would interfere with optimal
             participation in the trial or produce significant risk to the subject

         19. Inability to cooperate with study personnel