A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
Condition: Hyperphosphatemia; End-stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hyperphosphatemia
Intervention: ferric citrate
Intervention description: ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: ESRD; end-stage renal disease; end stage renal disease; hemodialysis; dialysis; kidney failure; renal failure; kidney; renal; phosphate binder; phosphorus

Summary:

      This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a
      treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant, nonlactating females

          -  Age > 18 years

          -  On thrice weekly hemodialysis for at least the previous 3 months prior to
             randomization

          -  Phosphorous levels ≥3.5mg/dL at Screening Visit

          -  On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate
             (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg
             tablets), or any combination of these agents

          -  Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50%

          -  Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Parathyroidectomy within 6 months prior to Screening

          -  Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal
             reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)

          -  History of documented inflammatory bowel disease or erosive esophagitis

          -  Serum Phosphorus levels >10.0 mg/dL documented in the 3 monthly laboratories (done
             routinely in the dialysis unit) in the 3 months prior to the Screening Visit

          -  History of multiple drug allergies

          -  History of malignancy in the last 5 years (treated cervical or skin cancer may be
             permitted if approved by CCC)

          -  Previous intolerance to oral ferric citrate

          -  Absolute requirement for oral iron therapy

          -  Absolute requirement for Vitamin C (multivitamins [Neprocaps, Renaphro, etc.] allowed)

          -  Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals

          -  Psychiatric disorder that interferes with the patient's ability to comply with the
             study protocol

          -  Inability to tolerate oral drug intake

          -  Planned surgery or hospitalization during the study (scheduled outpatient access
             surgery allowed)

          -  Any other medical condition that renders the patient unable to or unlikely to complete
             the study or that would interfere with optimal participation in the study or produce
             significant risk to the patient

          -  Receipt of any investigational drug within 30 days of randomization

          -  Inability to cooperate with study personnel or history of noncompliance