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Rockwell Medical, Inc. Message Board

  • faosto faosto Jul 11, 2013 11:41 PM Flag

    Way too much consternation on "dropout rate"

    Ok, so here's the deal: this trial, by design, was going to have a high number of people who had to be removed from the study. Why? Because pre-described safety protocols were put in place for hemoglobin counts that were either too high or two low at every check period (2 weeks and one month). And why would patients fall under or be over the safe range? Take a look at who was eligible to participate:"Adult patients with chronic kidney disease on regular hemodialysis, who were receiving stable doses of erythropoiesis stimulating agents (ESAs) and who were iron replete (as measured by serum transferrin saturation between 15 % to 40% and serum ferritin between 200 to 800 µg/L), were eligible for randomization. Patients who met the inclusion criteria entered a run-in period of 1 to 4 weeks. During the run-in, no study drug was administered, and no changes in the dose or route of administration of ESA were allowed. IV and oral iron products were not allowed from run-in through the end of randomized treatment."

    Get that? NO CHANGE IN THE DOSE OF ESA'S AND NO IV IRON ALLOWED! That, by design, was going to kick a significant number of people out of the trial once the safety flags came out BECAUSE NO CHANGE IN ESA DOSES MEANT THAT WITH SFP THE HEMOGLOBIN COUNTS COULD GET TOO HIGH, AND WITH PATIENTS REPLETE IN IRON BUT WITH NO IV IRON ALLOWED, a large percentage of people were going to fall under minimum iron levels and or hemoglobin levels during the course of the study. THE WHOLE POINT OF THIS STUDY WAS TO MEASURE AGAINST BASELINE THE POSITIVE (OR NEGATIVE) EFFECTS OF SFP, WITH ALL OTHER THINGS STAYING EQUAL.

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    • Their statistical analysis of the timing of the "dropouts" combined with the biodata will allow them to calculate on a post-trial basis what percentage reduction in ESA dosing is optimal, and what percentage reduction in IV iron is optimal IN COMBINATION WITH SFP. Rockwell never said and is not saying that SFP eliminates ESA dosing or IV IRON! But it significantly reduces it while maintaining hemoglobin levels and ferritin levels.

      • 1 Reply to faosto
      • blehair@gmail.com blehair Jul 12, 2013 12:07 AM Flag

        SFP's purpose is to reduce both ESA dosing and IV iron usage while maintaining Hgb levels between 9.5 and 12.5 Hgb/dL.

        PRIME showed that it reduces ESA dosage by 37%, which also highly suggests reduced usage of IV iron for SFP users.

        Higher ESA dosing and more IV iron usage corresponds to more AEs (along with their resultant costs) and 37% more expense on ESA doses (+amount that IV iron costs).

        Further, SFP provides these benefits without increasing ferritin storage levels which result from IV iron usage. This means that SFP is doing what IV iron does without the ferritin storage increase drawback.

        For thin profit margin dialysis centers (all of them, w/ is why RMTI's base profit margin is so thin as well), SFP will be a significant tool used to reduce dialysis centers' expenses. Because RMTI already has the network setup and functioning, the product costs for SFP and the base products will overlap.

        SFP revenue estimates are all in excess of $150M, and that's just for the DaVito (30% of US market) subset of the global patient population.

 
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