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Positive Results Reported for Iron-Delivery Drug in Phase III Trial
Hemoglobin maintained without increasing stored iron in hemodialysis patients (July 11)
Positive results have been reported from a long-term phase III efficacy study of SFP (Rockwell Medical), an investigational iron-delivery drug for the treatment of iron deficiency in patients with chronic kidney disease receiving hemodialysis.
SFP met the study’s primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to end-of-treatment. In addition, the drug met key secondary endpoints, including the maintenance of hemoglobin, the maintenance of reticulocyte hemoglobin, and an increase in serum iron pre- to post-treatment without an increase in ferritin.
The results of this study provide clinical data required for the filing of a new drug application (NDA) with the FDA.
The CRUISE-1 study met its primary efficacy endpoint, which was a change in hemoglobin from baseline to end-of-treatment between the SFP and placebo groups. The mean difference between SFP and placebo was 3.6 g/L in favor of SFP (P = 0.011).
At baseline, the two treatment groups had similar hemoglobin levels (109.6 g/L SFP and 109.0 g/L placebo). The mean adjusted change from baseline hemoglobin to the end of the randomized treatment period in the SFP group was 0.6 g/L. In the placebo group, there was a statistically significant decline of 3.0 g/L.
Reticulocyte hemoglobin, a marker of iron delivery to the bone marrow, was maintained at baseline levels in the SFP group during the randomized treatment, compared with a significant decrease in the placebo group. At end-of-treatment, there was a statistically significant 2.1% difference in favor of SFP (P < 0.001).
Serum ferritin, a marker of tissue iron stores, declined by 14.7% from baseline in the SFP arm, whereas the ferritin level declined by 28.2% in the placebo group (P < 0.001).
SFP is an iron compound that is delivered to hemodialysis patients via dialysate, replacing the 5 to 7 mg of iron lost during a dialysis treatment. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate.
Source: Rockwell Medical; July 11, 2013.