The CRUISE-1 study was a single-blind, placebo controlled, parallel group study comparing SFP (2µM [110 µg iron/L] delivered via hemodialysate concentrate) to placebo (standard hemodialysate concentrate). 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.
Patients who continued to meet inclusion criteria during the run-in period were randomized 1:1 to receive either SFP via dialysate or placebo (standard dialysate) in a blinded manner for up to 48 weeks. Patients received the designated study drug at each dialysis session during the randomized treatment period. Hemoglobin, the measurement for the primary endpoint, was assessed weekly, along with iron parameters every two weeks. Randomized patients could remain in the study for up to 48 weeks
Over the course of the study patients were not permitted to have their ESA dose adjusted from baseline dose, and were not permitted IV or oral iron. The study design incorporated a pre-defined protocol to address safety criteria and removed patients prior to 48 weeks who met any of the following removal criteria: 1) a need to change ESA dose for low or high (< 90 or > 120 g/L) hemoglobin values, 2) rapidly rising hemoglobin defined as > 115 g/L and an increase of 10 g/L over 4 weeks, or 3) serum ferritin < 100 µg/L. By withholding iron and not allowing ESA dose adjustment during the study period, the study was designed for removal of the majority of patients prior to end of study while demonstrating a statistically significant change in hemoglobin from Baseline to End-of-Treatment between the SFP and placebo groups. All patient hemoglobin values, no matter what time point patients were removed from the study due to the pre-defined protocol safety criteria, were included in the primary endpoint calculation. Patients removed from the study were transitioned into an open-label extension period. Patients could also be withdrawn from the randomized treatment period for transfusions, adverse events, protocol violations or by request of the patient or investigator.
The primary study population was the modified Intent-to-Treat (mITT) population, defined as all patients who were randomized, and received at least one dose of study drug, and had at least one post-baseline hemoglobin value during the randomized treatment period.
The primary outcome measure for this study was the mean change in hemoglobin level from baseline to the End-of-Treatment. End-of-Treatment was defined as the average of the hemoglobin levels during the last 1/6th of the randomized treatment period of each patient. A minimum of at least two on-study hemoglobin values were necessary for inclusion in the analysis. The primary outcome statistic was provided by an analysis of covariance (ANCOVA) for the change from baseline hemoglobin between treatment groups, using baseline hemoglobin value as a covariate.
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