Ferumoxytol (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 ferumoxytol 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 ferumoxytol 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 ferumoxytol. 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 ferumoxytol or oral iron. Ferumoxytol 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 ferumoxytol 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 ferumoxytol 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 1 Non-Dialysis

CKD Trial 2 Non-Dialysis

CKD Trial 3 Dialysis

FerumoxytolN = 226

Oral IronN = 77

FerumoxytolN = 228

Oral IronN = 76

Ferumoxytol N = 114

Oral IronN = 116

Baseline Hgbmean (SD), g/dL

9.9 (0.8)

9.9 (0.7)

10 (0.7)

10 (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)

1* (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)

381.7 (278.6)

6.9 (60.1)

233.9 (207)

-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 ferumoxytol for a total cumulative dose of 2.04 g. Overall, 69 patients received two additional 510 mg intravenous injections of ferumoxytol, 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 ferumoxytol-treated patients and 0.61 ±0.97 g/dL for iron sucrose-treated patients.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.