Randomized trial of activated vitamin D for acute kidney injury prevention in critically ill patients.
Despite promising laboratory data, giving critically ill patients at high risk of kidney injury active vitamin D (calcifediol or calcitriol) did not prevent acute kidney injury compared with placebo, though it did shift immune-related gene activity.
Background
Active vitamin D metabolites have potent immunomodulatory effects that attenuate AKI in animal models, motivating a clinical test of whether they prevent AKI in high-risk patients.
Study design
This phase 2, randomized, double-blind, three-arm trial compared oral calcifediol, calcitriol, and placebo in 150 critically ill adults at high risk of moderate-to-severe AKI. The primary endpoint was a hierarchical composite of death, kidney replacement therapy, and kidney injury within 7 days.
Key findings
The global rank score for the primary endpoint was similar for calcifediol versus placebo (P = 0.85) and calcitriol versus placebo (P = 0.58), and secondary endpoints occurred at similar rates. Calcitriol upregulated more monocyte genes and pathways (including interferon, oxidative phosphorylation, DNA repair, and heme metabolism) than calcifediol, but this did not translate into AKI protection.
Safety
Hypercalcemia was rare, occurring in 1 calcifediol-treated patient (1.7%), 1 calcitriol-treated patient (2.0%), and no placebo patients.
Category
Research
Source
JCI Insight
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