A 6-Month clinical practice pilot study of sucroferric oxyhydroxide on nutritional status in patients on peritoneal dialysis

Abstract

Background Hyperphosphatemia is common in patients on peritoneal dialysis (PD). Restricting dietary phosphorus often leads to a decrease in protein intake, which may result in hypoalbuminemia. The high pill burden of phosphate binders may also contribute to compromised appetite and dietary intake. Hypoalbuminemia is associated with an increased risk of morbidity and mortality in PD patients. The goal of this study was to determine if sucroferric oxyhydroxide improves albumin and self-reported measures of appetite in PD patients. Methods We performed a prospective, open-label, 6-month, pilot study of 17 adult PD patients from the Denver Metro Area. Patients had to use automated peritoneal dialysis for ≥ 3 months, have a serum albumin ≤ 3.8 g/dL, and have serum phosphate ≥ 5.5 mg/dL or ≤ 5.5 mg/dL on a binder other than SO. SO was titrated to a goal serum phosphate of < 5.5 mg/dL. The primary outcome was change in serum phosphate, albumin, and phosphorus-attuned albumin (defined as albumin divided by phosphorus) over 6 months. Results The mean (SD) age and dialysis vintage was 55 ± 13 years and 3.8 ± 2.7 years, respectively. Participants’ serum phosphate significantly decreased with fewer phosphate binder pills/day after switching to SO. There was no change in serum albumin, appetite, or dietary intake. However, participants had significant improvements in phosphorus-attuned albumin. Conclusion The transition to SO improved phosphorus control, phosphorus-attuned albumin, and pill burden. There were no significant changes in self-reported appetite or dietary intake during the study. These findings suggest that PD patients maintained nutritional status with SO therapy. Trial registration First registered at ClinicalTrials.gov (NCT04046263) on 06/08/2019.

Management of serum phosphorus over a 1-year follow-up in patients on peritoneal dialysis prescribed sucroferric oxyhydroxide as part of routine care: a retrospective analysis

“…In this real-world retrospective cohort study, PD patients prescribed SO as part of routine clinical care over a 1-year period experienced significant reductions in sP and PB pills per day, and increases in the percentage of patients who achieved sP ≤ 5.5 mg/dL or sP ≤ 4.5 mg/dL, suggesting improved sP management with a concurrent reduction in pill burden. These findings are consistent with our observations in a smaller cohort of patients on PD in 2014–2015 and the results of previous studies in patients on PD or hemodialysis [ 11 – 13 , 15 , 16 ]. Compared to our previous real-world analysis of SO initiation in patients on PD in 2014–2015, patients in the completers cohort of the current study were older (55.2 vs. 50.6 years) but were newer to dialysis (19.9 vs. 29.3 months) and had lower sP at baseline (6.26 vs. 6.59 mg/dL).…”

“…It has been suggested that dietary intake may improve with SO vs. other binders, given the impact of regimens with higher pill burdens on appetite [ 16 ]. A recent pilot clinical practice study documented similar increases in phosphorus-attuned albumin but did not find any significant changes in patient-reported appetite or dietary intake among PD patients initiating SO [ 13 ].…”

“…Clinical and observational studies have shown the effectiveness of the iron-based, non-calcium, chewable PB, sucroferric oxyhydroxide (SO; VELPHORO®, Fresenius Medical Care Renal Therapies Group, Waltham, MA, USA) in controlling sP in patients with ESKD on PD [ 11 – 13 ]. A real-world retrospective analysis of patients with PD prescribed SO for 6 months demonstrated an association between SO initiation and lower sP, improved sP target achievement, and reduced PB pill burden [ 12 ].…”