Hemoglobin (g/dL)

Mean (SD)

Cohort 1

Cohort 2

Injectafer
(N=244)

Oral Iron
(N=251)

Injectafer
(N=245)

IV SCa
(N=237)

Baseline         

10.6 (1.0)

10.6 (1.0)

9.1 (1.6)

9.0 (1.5)

Highest Value

12.2 (1.1)

11.4 (1.2)

12.0 (1.2)

11.2 (1.3)
Change (from baseline to highest value)
1.6 (1.2)

0.8 (0.8)

2.9 (1.6)

2.2 (1.3)

p-value
0.001

0.001
SD=standard deviation; a: Intravenous iron per standard of care
Increases from baseline in mean ferritin (264.2 ± 224.2 ng/mL in Cohort 1 and 218.2 ± 211.4 ng/mL in Cohort 2), and transferrin saturation (13 ± 16% in Cohort 1 and 20 ± 15% in Cohort 2) were observed at Day 35 in Injectafer-treated patients.
14.2 Trial 2: Iron Deficiency Anemia in Patients with Non-Dialysis Dependent Chronic Kidney Disease
Trial 2: REPAIR-IDA, Randomized eva luation of efficacy and safety of Ferric carboxymaltose in Patients with iron deficiency Anemia and Impaired Renal function, (NCT00981045) was a randomized, open-label, controlled clinical study in patients with non-dialysis dependent chronic kidney disease. Inclusion criteria included hemoglobin (Hb) ≤ 11.5 g/dL, ferritin ≤ 100 ng/mL or ferritin ≤ 300 ng/mL when transferrin saturation (TSAT) ≤ 30%.  Study patients were randomized to either Injectafer or Venofer. The mean age of study patients was 67 years (range, 19 to 101); 64% were female; 54% were Caucasian, 26% were African American, 18% Hispanics, and 2% were other races.
Table 3 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 56 or time of intervention. 
Table 3. Mean Change in Hemoglobin From Baseline to the Highest Value Between Baseline  and Day 56 or Time of Intervention (Modified Intent‑to‑Treat Population)
Hemoglobin (g/dL)
Mean (SD)
Injectafer
(N=1249)
Venofer
(N=1244)
Baseline
10.3 (0.8)
10.3 (0.8)
Highest Value
11.4 (1.2)
11.3 (1.1)
Change (from baseline to highest value)
1.1 (1.0)
0.9 (0.92)
Treatment Difference (95% CI)
0.21 (0.13, 0.28)
Increases from baseline in mean ferritin (734.7 ± 337.8 ng/mL), and transferrin saturation (30 ± 17%) were observed prior to Day 56 in Injectafer-treated patients.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC 0517-0650-01           750 mg iron/15 mL Single-Dose Vial        Individually boxed
NDC 0517-0650-02           750 mg iron/15 mL Single-Dose Vial        Packages of 2
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature].  Do not freeze.
17 PATIENT COUNSELING INFORMATION
Question patients regarding any prior history of reactions to parenteral iron products.
Advise patients of the risks associated with Injectafer.
Advise patients to report any signs and symptoms of hypersensitivity that may develop during and following Injectafe