Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?

Sensitivity and specificity of baseline automated red cell indices, peripheral smear red cell indices, and iron indices for diagnosis of iron deficiency

Sensitivity and specificity of baseline peripheral smear hypochromic RBCs \>10%, peripheral smear red blood cell anisocytosis \> 10%, percentage hypochromic mature red cells (%HYPOm) \>6%, reticulocyte hemoglobin content (CHr) \< 30 pg, transferrin saturation (TSAT), and serum ferritin, for the diagnosis of iron deficiency anemia. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) \>1% at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.

Time frame: Baseline

Optimum cutoff for baseline automated red cell indices for the diagnosis of iron deficiency anemia using ROC curve analysis

Optimum cutoff of baseline %HYPOm and CHr for the diagnosis of iron deficiency anemia using ROC curve analysis. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) \>1% at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.

Time frame: Baseline

Sensitivity and specificity of baseline peripheral blood smear hypochromia, peripheral blood smear anisocytosis and automated red cell indices for the diagnosis of iron deficiency anemia in participants with TSAT < 30% and TSAT > =30%.

Sensitivity and specificity of \> 10% hypochromic red blood cells on peripheral blood smear, \>10% red blood cell anisocytosis on peripheral blood smear, %HYPOm \> 6%, and CHr \< 30 pg measured at baseline, for the diagnosis of iron deficiency anemia in participants with baseline TSAT \< 30% and TSAT \> 30% respectively. Iron deficiency anemia is defined by an increase in corrected reticulocyte index (reticulocyte % x hematocrit/40) \>1% at 7 days and/or increase in hemoglobin by ≥1 g/dL 30 days after administration of IV FCM in the FCM +placebo arm.