Upacicalcet May Preserve Albumin Levels in Hemodialysis Patients With SHPT: Study
Japan: A post hoc analysis of a randomized trial found that upacicalcet, a novel injectable calcimimetic, may attenuate the gradual decline in serum albumin levels among patients receiving hemodialysis for secondary hyperparathyroidism (SHPT). While albumin levels tended to decrease among patients receiving placebo, they remained relatively stable with upacicalcet treatment, raising the possibility that effective parathyroid hormone (PTH) control could help limit protein-energy wasting.
Published in the American Journal of Nephrology, the study by Hirotaka Komaba, Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan, and colleagues explored whether lowering PTH with upacicalcet could influence serum albumin, a commonly used surrogate marker of nutritional status and protein-energy wasting in patients undergoing dialysis.
Elevated PTH has been linked to metabolic changes that could contribute to the loss of adipose and muscle tissue. Experimental studies suggest that PTH can promote the browning of adipose tissue, increasing resting energy expenditure and potentially contributing to tissue wasting in kidney failure. However, whether controlling PTH can produce similar benefits in humans remains uncertain.
The researchers conducted a post hoc analysis of a phase 3, double-blind, placebo-controlled trial involving patients on hemodialysis with SHPT. Participants were randomized in a 2:1 ratio to receive either upacicalcet or placebo after each dialysis session for 24 weeks. Changes in serum albumin over time were compared between the treatment groups using repeated-measures statistical models, while linear mixed-effects analysis was used to estimate the rate of change in albumin levels.
A total of 145 patients were included, comprising 99 in the upacicalcet group and 46 in the placebo group.
Key findings
- Serum albumin levels tended to decline in the placebo group but remained comparatively stable among patients receiving upacicalcet.
- A significant treatment-by-time interaction indicated different albumin trajectories between the two groups.
- The estimated annual decline in serum albumin was less pronounced with upacicalcet, although the between-group difference of 0.09 g/dL per year did not reach statistical significance.
- The findings suggest that PTH suppression with upacicalcet may help slow the progressive reduction in albumin levels in hemodialysis patients with SHPT.
The findings suggest that calcimimetic therapy may have benefits beyond PTH control by potentially supporting nutritional status and reducing protein-energy wasting. Upacicalcet’s relatively lower incidence of gastrointestinal adverse effects may also help maintain nutritional intake.
The study has several limitations. As a post hoc analysis, the findings were based on secondary outcomes not prespecified in the original trial. Serum albumin was the only marker of protein-energy wasting, with no assessment of other nutritional or body-composition measures. The inclusion of only Japanese participants limits generalizability, while the effects of other calcimimetics remain uncertain.
The authors concluded that PTH reduction with upacicalcet may attenuate serum albumin decline in hemodialysis patients with SHPT. Larger, longer-term studies using broader measures of protein-energy wasting are needed to establish whether this translates into meaningful clinical benefits.
Reference:
Hirotaka Komaba, Seigo Akari, Yoshiyuki Ono, Masafumi Fukagawa; Upacicalcet Preserves Albumin Levels in Patients on Hemodialysis with Secondary Hyperparathyroidism: A post hoc Analysis of a Randomized Trial. Am J Nephrol 20 July 2026; 57 (4): 461–467. https://doi.org/10.1159/000548738
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