Study design and treatment
PD
Patients who met the selection criteria entered a ≤14-day screening period to assess eligibility. Eligible patients were enrolled sequentially in one of two dose groups in which they received a single IV dose of FCM (Vifor Pharma Ltd., St. Gallen, Switzerland) (either 7.5 mg/kg or 15 mg/kg, with a maximum total dose of 750 mg). Enrollment in the group to receive the higher dose of FCM (15 mg/kg) began after all patients in the lower dose group (FCM 7.5 mg/kg) had received study drug and been observed for 4 weeks post-dose with no safety concerns as determined by the DSMB on the basis of an interim analysis of the FCM 7.5 mg/kg cohort.FCM was administered as an undiluted solution at a rate of 100 mg/min. Doses less than 100 mg were administered as a slow undiluted IV push injection within 1 min. All patients were followed for 35 days. After infusion of FCM on Day 0, patients returned to the clinic at 24, 48, and 72 h post-dose, and subsequently on study Days 14, 28, and 35 for safety, PK, and PD assessments.