Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
Condition: End-Stage Renal Disease (ESRD)
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Standard Bicarbonate Solution; Soluble Ferric Pyrophosphate; Soluble Ferric Pyrophosphate; Soluble Ferric Pyrophosphate; Soluble Ferric Pyrophosphate
Intervention description: Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.; Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.; Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.; Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.; Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Intervention MeSH terms: Iron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subjects with ESRD receiving chronic Hemodialysis

Summary:

      The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble
      Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during
      chronic hemodialysis.
    

Eligibility criteria:

        Selected Inclusion Criteria:

          1. Adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal
             disease (ESRD) three times a week

          2. Hemoglobin (Hgb) values on two successive screening/baseline measures immediately
             prior to the start of the study averaging 10.1 to 11.5 grams/ deciliter (g/dL),
             inclusive

          3. Transferrin Saturation (TSAT) values that average 20% or more, but not exceeding 35%,
             prior to dialysis measured during the screening period

          4. Ferritin values that average 200 to 800 micrograms/ liter (µg/L), inclusive, measured
             during the screening period. An average ferritin above 800 µg/L but no greater than
             1200 µg/L is allowed if the average TSAT is 20% to no greater than 25%.

          5. Except for vascular access surgery, subject has no hospitalization in previous three
             months for a significant illness that, in the opinion of the Investigator, confers a
             significant risk of hospitalization during the course of the study. No blood
             transfusions within the last 4 weeks are allowed.

          6. Subject has an adequate dialyzer blood flow rate that is acceptable to the Principal
             Investigator

        Exclusion Criteria:

          1. Hemoglobin (Hgb) values on two successive baseline/screening measurements that average
             ≥ 11.6g/dL

          2. Subject with a current malignancy involving a site other than skin

          3. Subject with a history of drug or alcohol abuse within the last six months

          4. Subject believed to be unable to complete the entire study (e.g., due to a concurrent
             disease, life expectancy of less than a year)

          5. Subject who the Principal Investigator considers will be placed at increased risk by
             the study procedures

          6. Subject requiring hemodialysis more than 3 times per week on a regular basis.

          7. Subject who is unable to discontinue oral iron or intravenous iron supplements for the
             duration of the study

          8. Subject who is pregnant

          9. Subject considered incompetent to give an informed consent

         10. Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days
             or during screening

         11. Subject with known HIV infection (if this is not known, no HIV testing will be
             performed)

         12. Subject with cirrhosis of the liver based on histological criteria or clinical
             criteria (presence of ascites, esophageal varices, spider nevi, or history of hepatic
             encephalopathy). Subject with hepatitis C, in the absence of cirrhosis, is not
             excluded from participation in the study if ALT and AST levels are below 2 times the
             upper limit of normal consistently during the 2 months preceding enrollment

         13. Subject with active tuberculosis, fungal, viral, or parasitic infection

         14. Subject with active bacterial infection requiring antibiotic therapy

         15. Subject with pre-dialysis Corrected Q-wave to T-wave (QTc) interval ≥ 470 milliseconds
             (ms)

         16. Subject with a history of hypokalemia, decompensated heart failure, or family history
             of Long QT Syndrome that in the Investigator's judgment poses a risk for Torsades de
             Pointe during the study

         17. Subject using concomitant medications known to prolong QT/QTc interval (See Appendix
             I, TABLE A)

         18. Subject receiving more than 60,000 units or 120 micrograms of erythropoietin (Epogen®,
             Procrit®, or Aranesp®) per week

         19. Subject has participated in another clinical trial within 30 days of signing Informed
             Consent