A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease

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.