You are here

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

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

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.

More Headlines

Liver Fluke Infestation Affects Almost 2.5 Million People Globally
Policy Could Be Life-Changing for People With Spinal Cord Injury
Test Determines Severity of Pain, Helps Physicians Select Best Options
Intratumoral Injection Stimulates Immune Activation
Diabetes and Cancer Patients Could Soon Avoid Injections
Early Cancer Development May Begin in Just 30 Minutes