This study led to the FDA approval of Venofer. Always refer to the approved Full Prescribing Information and Important Safety Information below.

Venofer improves anemia markers in patients who are hemodialysis-dependent with chronic kidney disease (HDD-CKD).¹

HDD-CKD patients treated with Venofer showed significant increases in hemoglobin, hematocrit, serum ferritin and transferrin saturation.¹

Study Design/Methods^1,2

Study C was a multicenter, open-label study in patients with HDD-CKD. This study enrolled patients with hemoglobin ≤10 g/dL, serum transferrin saturation ≤20% and serum ferritin ≤200 ng/mL who were undergoing maintenance hemodialysis 2 to 3 times weekly. The mean age of the patients enrolled in this study was 41 years, with ages ranging from 16 to 70 years. Of 130 patients evaluated for efficacy in this study, 68 (52%) were male and 62 (48%) were female. Forty-eight percent of the patients had previously been treated with oral iron.

Exclusion criteria included: Inflammatory disease; causes of anemia other than chronic renal failure (CRF) or iron deficiency; asthma; pregnancy; bacterial or viral infection; severe cardiac, hepatic, or psychiatric disorder; anticipated need for transfusion, surgery, or transplantation during the study period; and evidence of iron overload (transferrin saturation [TSAT] 50% or ferritin 800 ng/mL).

Venofer was administered in doses of 100 mg during sequential dialysis sessions until a predetermined (calculated) total dose of iron was administered. A 50 mg dose (2.5 mL) was given to patients within 2 weeks of study entry as a test dose. Twenty-seven patients (20%) were receiving erythropoietin treatment at study entry, and they continued to receive the same erythropoietin dose for the duration of the study.

Increases in baseline at week 2¹

Hemoglobin

Hematocrit

Serum Ferritin

Transferrin Saturation

The modified intention-to-treat population consisted of 131 patients. Significant (P < 0.0001) increases from baseline in mean hemoglobin (1.7 g/dL), hematocrit (5%), serum ferritin (434.6 ng/mL) and serum transferrin saturation (14%) were observed at week 2 of the observation period and these values remained significantly increased (P < 0.0001) at week 4 of the observational period.

Mean ratio of hematology and iron studies of observation week 2 and post-study from baseline in evaluable patients (n=105)²

*Estimate of observation week 2 or post-study over baseline means ratio from analysis of variance of log-transformed data.

^†95% confidence interval for mean ratio after logarithmic transformation of data.

TiBC, total iron binding capacity; SD, standard deviation.

Reviewer's table based on the sponsor's table 16, 17, 19, and 20 in NDA Vol. 1.18, pp. 192-193, 195-196.

Adverse events reported during study²

The modified intention-to-treat population consisted of 131 patients. A total of 117 (89%) patients (111 during treatment period and 86 during the observation period) reported adverse events during the study. Hypotension (53%), cramps (44%), nausea (27%), headache (16%), vomiting (14%) and chest pain (10%) were the most frequently reported adverse events during the study, also during treatment period. Only 29 (22%) of adverse events during treatment period and 5 (5%) of events during observation period were judged to be possibly related to Venofer by treating physician.^1,2