Fontanez week 2 assignment

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Fontanez week 2 assignment

Download powerpoint Figure 3. Iron parameters by study time point during the week active control period. Box plots display 5th, 25th, 50th, 75th, and 95th percentiles. AC, active control; FC, ferric citrate.

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Through 1 month after drug discontinuation in the week active control period, 4. No deaths were attributed to the study drug. The corresponding percentages of subjects in the ferric citrate and active control groups with infection SAEs were The proportions of patients with recorded AEs in the noted categories were increased slightly by adding patients who had their first recorded AEs in those categories after discontinuation of the Fontanez week 2 assignment drug Supplemental Appendix.

Subjects who stopped the study drug were followed in the study, if able, with all study procedures.

Fontanez week 2 assignment

Available evidence does not support the hypothetical concern that the lower overall rates of SAEs and SAEs in GI, cardiac, and infection categories were caused by censoring of subjects who stopped study drug Supplemental Appendix. Discussion Most patients on dialysis require phosphate binding and the repletion of iron stores.

Our study, on the basis of a prospectively designated sequential gatekeeping strategy, achieved all of the five predesignated outcomes: No other approved phosphate binder increases iron stores and decreases iv iron and ESA usage. Oral ferric citrate had been studied as a phosphate binder in several preliminary studies.

All previous phosphate binders were deemed to be efficacious in comparisons with placebo. The trial design that we selected shows the efficacy of ferric citrate in lowering serum phosphorus compared with placebo in subjects who had been maintained on ferric citrate for 52 weeks in the active control period.

This trial also shows that ferric citrate provides similar control of phosphorus compared with active control over 52 weeks. Our sequential trial design, with the placebo period following the year-long active control period, more closely replicates efficacy in a real patient care setting, in which patients only achieve phosphorus control if they are maintained on the binder over a longer time than could be achieved in a short placebo trial.

Also, ferric citrate had a lower average pill burden compared with sevelamer carbonate, with comparable phosphorus control. The few currently available phosphate binders have limitations, including aluminum toxicity, 12 diarrhea, 13 — 17 hypercalcemia, 14 and patient tolerability issues.

This result was largely because of more GI non-serious AEs, such as diarrhea and bloating, early in the study in subjects receiving ferric citrate Supplemental Appendix.

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Of note, a study entry criterion was tolerability to calcium acetate or sevelamer carbonate, and therefore, patients who had GI intolerance to these active control drugs were excluded from the study.

Enrolling subjects with known intolerance to these drugs could have led to their immediate withdrawal if randomized to active control in many cases.

Patients on dialysis would benefit from another binder choice independent of the other attributes of ferric citrate. The week active control period was a randomized, standalone clinical trial, and it showed that ferric citrate administration over 52 weeks increased iron stores, which was shown by increased serum ferritin, serum iron, and transferrin saturation, despite significantly reducing administration of iv iron and ESA usage.

Patients on dialysis lose blood, are commonly iron deficient, and require sufficient iron stores for ESA responsiveness.

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Although subjects receiving ferric citrate achieved higher iron stores than those receiving active control, they received significantly less iv iron, with the majority no longer requiring iv iron in the last 6 months of the week active control period.

This result is presumably secondary to the GI absorption of iron from ferric citrate. It is unlikely that the increases in serum ferritin were related to inflammation, because TSAT also increased, and subjects on ferric citrate had evidence of less inflammation, such as fewer infection-associated SAEs, than subjects on active control.

Ferric citrate in this study reduced ESA usage, whereas slightly higher hemoglobin values were achieved compared with active control. Indeed, our study showed that subjects on ferric citrate have higher iron stores and decreased iv iron and ESA use.

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Unlike iv iron currently administered in dialysis units, oral iron absorption is tightly regulated in the GI tract. This process and subsequent iron passage into the plasma are tightly regulated by iron regulatory proteins and hepcidin, respectively.

As result of this regulation, iron absorption is restricted when iron stores are sufficient and increased when iron stores are deficient.A 2-week washout period was followed by a week randomized, open-label, active control period to determine the safety of ferric citrate as well as its capacity to supplement iron stores and reduce iv iron and ESA usage.

The face-to-face discussion of and assignment of work are central to the process. The extent to which it is managed well will give meaning to the preparatory and follow-up work done in Phases 1 and 3.

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Fontanez week 2 assignment

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