Experience

Venofer® landmark clinical studies

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Study Design/METHODS

Study A was a multicenter, open-label, historically controlled study in 101 patients with HDD-CKD and IDA. Of the 101 patients, 77 were treated with Venofer® (iron sucrose) injection, USP, and 24 were in the historical control group. Eligibility criteria for Venofer treatment included patients undergoing chronic hemodialysis and receiving erythropoietin, with a hemoglobin level between 8.0 and 11.0 g/dL, transferrin saturation <20% and serum ferritin <300 ng/mL. The mean age of the patients was 65 years, with ages ranging from 31 to 85 years. Of the 77 patients, 44 (57%) were male and 33 (43%) were female. Venofer 100 mg was administered at 10 consecutive dialysis sessions, either as a slow injection or as a slow infusion. The historical control population consisted of 24 patients with similar ferritin levels as patients treated with Venofer, who were off intravenous iron for at least 2 weeks and who had received erythropoietin therapy, with hematocrit averaging 31 to 36 for at least 2 months prior to study entry. The mean age of patients in the historical control group was 56 years, with an age range of 29 to 80 years. Patient age and serum ferritin level were similar between treatment and historical control population.

Results

Venofer-treated population showed a greater increase in hemoglobin and hematocrit than patients in the historical control population.

Changes From Baseline in Hemoglobin and Hematocrit

Efficacy
Parameters

Hemoglobin (g/dL)

Hematocrit (%)

Efficacy Parameters

End of Treatment

End of Treatment

Venofer
(n=69)

Historical Control
(n=18)

Hemoglobin (g/dL)

1.0 ± 0.12*

0.0 ± 0.21

Hematocrit (%)

3.1 ± 0.37*

-0.3 ± 0.65

Efficacy Parameters

2-Week Follow-Up

2-Week Follow-Up

Venofer
(n=73)

Historical Control
(n=18)

Hemoglobin (g/dL)

1.3 ± 0.14*

-0.6 ± 0.24

Hematocrit (%)

3.6 ± 0.44*

-1.2 ± 0.76

Efficacy Parameters

5-Week Follow-Up

5-Week Follow-Up

Venofer
(n=71)

Historical Control
(n=15)

Hemoglobin (g/dL)

1.2 ± 0.17**

-0.1 ± 0.23

Hematocrit (%)

3.3 ± 0.54

0.2 ± 0.86

**P < 0.01 and *P < 0.05 compared to historical control from ANCOVA analysis with baseline hemoglobin, serum ferritin and erythropoietin dose as covariates.

Serum ferritin increased at endpoint of study from baseline in the Venofer-treated population (165.3 ± 24.2 ng/mL) compared to the historical control population (-27.6 ± 9.5 ng/mL). Transferrin saturation increased at endpoint of study from baseline in the Venofer-treated population (8.8% ± 1.6%) compared to this historical control population (-5.1% ± 4.3%).

STUDY REFERENCE

1. Charytan C, Levin N, Al-Saloum M, et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis. 2001;37:300-307.