Clinical trial NCT02595437 (phase 1/phase 2, status: completed)
Conditions: end stage renal disease
ICD codes: N18.6, I12.0, I13.11, I13.2
Drugs: triferic
SMILES: [Fe+3].[Fe+3].[Fe+3].[Fe+3].[O-]P([O-])(=O)OP([O-])([O-])=O.[O-]P([O-])(=O)OP([O-])([O-])=O.[O-]P([O-])(=O)OP([O-])([O-])=O
Eligibility criteria:

        Inclusion Criteria:

        A patient will be eligible for inclusion in the study only if all of the following criteria
        are met:

          1. Parents/legal guardians of the patient have the ability to understand the requirements
             of the study and have demonstrated a willingness to have their child comply with all
             study procedures by signing an institutional review board-approved informed consent
             form. Where applicable, assent of the patient has also been obtained for all study
             procedures prior to any study-related activities.

          2. Patient is <18 years of age at screening.

          3. Patient has chronic kidney disease receiving in-center hemodialysis at least twice
             weekly for at least 1 month prior to screening.

          4. Patient is receiving adequate hemodialysis as assessed by the investigator and based
             on a single pool Kt/V measurement >1.2.

          5. Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to
             support blood flows for hemodialysis treatment.

          6. Patient has a body mass of 11 lbs (5 kg).

          7. Patient is iron-replete as measured by a TSAT 20% and a ferritin >100 micrograms/L at
             screening.

          8. Patient has a whole blood Hgb concentration of 10.0 g/dL at screening.

          9. If patient is receiving ESA, the dose has been stable (unchanged) for at least 3 weeks
             prior to Baseline admission.

         10. Patient has appropriate laboratory values for their disease state at screening (per
             investigator judgment).

         11. Patient has no significant abnormal findings on physical examination that would
             preclude participation in the study.

         12. If the patient is female, she must be pre-pubertal, have had documented surgical
             sterilization prior to Baseline admission, or be practicing adequate birth control.
             All female patients 9 years of age and older, and also any who have reached menarche
             before age 9 years, must have a negative serum pregnancy test during screening. It is
             the investigator's responsibility to determine whether the patient has adequate birth
             control for study participation.

        Exclusion Criteria:

        A patient will not be eligible for inclusion in the study if any of the following criteria
        apply:

          1. Patient is positive for human immunodeficiency virus (HIV) or hepatitis B by history.

          2. Patient has an acute illness within 1 week of Baseline admission (patient may be
             screened again 2 weeks post resolution of the acute illness).

          3. Patient is receiving intravenous or oral antibiotics or antifungals for any infectious
             process. Prophylactic antibiotics administered on a regular basis are allowed.

          4. Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus
             erythematosus, acute or chronic active hepatitis, etc.).

          5. Patient has participated in an investigational drug study within the 30 days prior to
             Baseline admission.

          6. Administration of IV or oral iron supplements within 2 weeks prior to Baseline
             admission.