Feraheme (Page 5 of 6)

14.2 Iron Deficiency Anemia in Patients with Chronic Kidney Disease

Trial 62745-7 (referred to as CKD Trial 1) (NCT 00255437), Trial 62745-6 (referred to as CKD Trial 2) (NCT 00255424), and Trial 62745-5 (referred to as CKD Trial 3) (NCT 00233597).

The safety and efficacy of Feraheme for the episodic treatment of iron deficiency anemia in patients with CKD were assessed in three randomized, open-label, controlled clinical trials (CKD Trial 1, 2 and 3) where Feraheme was administered as a rapid intravenous injection (prior method of administration — no longer approved). These trials also included an uncontrolled, follow-up phase in which patients with persistent iron deficiency anemia could receive two additional 510 mg intravenous injections of Feraheme. The major efficacy results from the controlled phase of each study are shown in Table 5.

In all three trials, patients with CKD and iron deficiency anemia were randomized to treatment with Feraheme or oral iron. Feraheme was administered as two 510 mg undiluted intravenous injections and oral iron (ferrous fumarate) was administered as a total daily dose of 200 mg elemental iron daily for 21 days. The major trial outcomes assessed the change in hemoglobin from baseline to Day 35. CKD Trial 1 and 2 enrolled patients with non-dialysis dependent CKD and CKD Trial 3 enrolled patients who were undergoing hemodialysis.

In CKD Trial 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races. In the Feraheme and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at baseline.

In CKD Trial 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races. In the Feraheme and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at baseline.

In CKD Trial 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races. All patients were receiving ESAs.

Table 5 shows the Baseline and mean change to Day 35 in hemoglobin (Hgb, g/dL), transferrin saturation (TSAT, %) and ferritin (ng/mL) in each treatment group for Trial 1, 2, and 3.

Table 5: Changes from Baseline to Day 35 in Hemoglobin (Hgb), Transferrin Saturation and Ferritin (Intent to Treat Population) in CKD Trials 1, 2 and 3
* p≤0.001 for main efficacy endpoint
ENDPOINT CKD Trial 1Non-Dialysis CKD Trial 2Non-Dialysis CKD Trial 3Dialysis
Feraheme N = 226 Oral IronN = 77 Feraheme N = 228 Oral IronN = 76 Feraheme N = 114 Oral IronN = 116
Baseline Hgbmean (SD), g/dL 9.9 (0.8) 9.9 (0.7) 10.0 (0.7) 10.0 (0.8) 10.6 (0.7) 10.7(0.6)
Hgb change from Baseline at Day 35 mean (SD), g/dL 1.2* (1.3) 0.5(1.0) 0.8* (1.2) 0.2 (1.0) 1.0*(1.1) 0.5 (1.1)
Baseline TSAT mean (SD), % 9.8 (5.4) 10.4 (5.2) 11.3 (6.1) 10.1 (5.5) 15.7(7.2) 15.9 (6.3)
TSAT change from Baseline at Day 35 mean (SD), % 9.2 (9.4) 0.3 (4.7) 9.8 (9.2) 1.3 (6.4) 6.4 (12.6) 0.6 (8.3)
Baseline ferritin mean (SD), ng/mL 123.7 (125.4) 146.2 (136.3) 146.1 (173.6) 143.5 (144.9) 340.5 (159.1) 357.6 (171.7)
Ferritin change from Baseline at Day 35 mean (SD), ng/mL 300.7 (214.9) 0.3 (82.0) 381.7 (278.6) 6.9 (60.1) 233.9 (207.0) -59.2 (106.2)

Following completion of the controlled phase of each of the Phase 3 trials, patients who were iron deficient and anemic could receive two additional 510 mg intravenous injections of Feraheme for a total cumulative dose of 2.04 g. Overall, 69 patients received two additional 510 mg intravenous injections of Feraheme, and on Day 35 following these additional injections, the majority of these patients (70%) experienced an increase in hemoglobin and iron parameters (TSAT and ferritin). The mean change (±SD) in hemoglobin level from the retreatment baseline for patients with an increase in hemoglobin was 0.86 (± 0.68) g/dL and was 0.5 (± 0.8) g/dL for all patients.

In a randomized, controlled clinical trial of 162 IDA patients with CKD (92 Non-Dialysis and 70 on Dialysis), mean change in hemoglobin from Baseline to Week 5 was 0.71 ±1.03 g/dL for Feraheme-treated patients and 0.61 ±0.97 g/dL for iron sucrose-treated patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Feraheme is available in single-dose vials in the following package sizes (Table 6).

Table 6: Feraheme Packaging Description
NDC Code Dose / Total volume per vial Vials / Carton
NDC 59338-775-01 510 mg/ 17 mL 1
NDC 59338-775-10 510 mg/ 17 mL 10

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