A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
Condition: End Stage Renal Disease; Hyperphosphatemia; Chronic Inflammation
MeSH terms: Kidney Failure, Chronic; Hyperphosphatemia; Inflammation
Intervention: Ferric Citrate
Intervention description: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: This study will be designed as a single arm, prospective, experimental trial of 45 hemodialysis patients. Patients on hemodialysis at least 6 months and receiving a phosphate binder with serum phosphorus levels between 2.5 and 8.0 mg/dL, normal serum calcium levels, and on maintenance iron therapy are potentially eligible. Participants will receive ferric citrate after at least a 2 week washout period from previous phosphate binders if phosphorus is ≥ 5.5 mg/dl, calcium is within the normal range and ferritin ≥ 200 and < 600 ng/ml. Ferric citrate will be titrated to maintain serum phosphorus and calcium within acceptable levels. Inflammatory markers and lipid levels will be tested at 0, 3, and 6 months.
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis
      is 10-100 times higher than the normal population. This is due in part to high levels of
      inflammation and vascular calcification found in these patients. Phosphate binders,
      particularly non-calcium based phosphate binders, may decrease cardiovascular risk by
      decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based
      phosphate binder with approximately 210 mg of ferric iron has recently been approved for
      patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid
      levels is unknown but investigators hypothesize that ferric citrate has the potential to
      improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous
      iron requirements and by improving lipid metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hemodialysis treatment for ≥ 6 months

          -  Phosphate binder treatment for ≥ to 1 month

          -  Maintenance iron therapy with no more than 125mg IV iron weekly≥ to 1 month

          -  Serum phosphorus levels between 2.5 and 8 at screening

          -  Serum phosphorus ≥ to 6.0 mg/dL after a 2 week washout period.

          -  Serum ferritin ≥ 200 and < 600ng/ml after a 2 week washout period

          -  Serum calcium levels within normal range

          -  Predicted survival greater than 6 months

        Exclusion Criteria:

          -  Intact PTH< 70 pg/ml or > 1,000 pg/ml

          -  Oral iron use

          -  Vitamin C supplement use

          -  Parathyroidectomy

          -  Active malignancy

          -  Hemodialysis via an intravenous catheter or arteriovenous (AV) graft

          -  Received > 250mg of IV iron over the two weeks prior to screening

          -  Whole blood transfusion within 3 months prior to screening

          -  Active bleeding other than from the dialysis access

          -  Hospitalization within one month prior to screening

          -  current infection

          -  Ongoing or uncontrolled inflammatory disorder

          -  Liver cirrhosis

          -  Likelihood of imminent renal transplantation