A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease; Iron-deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: IV Iron; Ferrous Sulfate
Intervention description: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.; Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; iron; kidney disease; progression; glomerular filtration rate

Summary:

      The long-term goal is to assess the fall in kidney function measured by glomerular filtration
      rate (GFR) when patients with chronic kidney disease (CKD) are exposed to intravenous iron
      (IVIR). We hypothesize that in subjects with mild to moderate CKD, infusion of intravenous
      iron (IVIR), will generate oxidative stress and cause an inflammatory response that will be
      associated with a more rapid decline in glomerular filtration rate (GFR) compared to oral
      iron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Calculated GFR by MDRD formula < or = 60ml/min/1.73m2. We will use the MDRD formula
             that incorporates serum creatinine, age, race and sex, but not albumin, and blood urea
             nitrogen.

          -  Presence of anemia and iron deficiency. Anemia will be defined as blood hemoglobin
             concentration <12g/dL and iron deficiency will be defined using National Kidney
             Foundation/Kidney Disease Outcome Quality Initiative (NFK-K/DOQI) Guidelines as serum
             ferritin concentration of <100ng/mL or serum transferrin saturation of <25%.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women or women who are planning to become pregnant or those
             not using a reliable form of contraception (oral contraceptives, condoms, and
             diaphragms will be considered reliable).

          -  Known hypersensitivity to iron sucrose (Venofer), iothalamate meglumine (Conray 60,
             Mallinckrodt) or iodine.

          -  Anemia that requires RBD transfusion (Hgb <8g/dL) or may potentially need transfusion
             (active gastrointestinal bleeding). It would be unsafe to withdraw 150 mL blood over
             the study in such anemic patients.

          -  Presence of acute renal failure defined as an increase in the baseline serum
             creatinine concentration of 0.5 mg/dl over 48 hours. This would produce oxidative
             stress by itself, may give unreliable rate of decline in renal function and may
             confound results.

          -  History of IVIR use within 1 month of the study (may confound results of the study if
             the baseline oxidative stress is increased).

          -  Evidence of iron overload (serum ferritin >800ng/nl or transferrin saturation >50%)

          -  Anemia not caused by iron deficiency eg. sickle cell anemia.

          -  Surgery or systemic or urinary tract infection within 1 month.

          -  Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled
             corticosteroids will be permitted.