Published by:
Strugnell SA, et al. Abstract TH-OR19. Presented at: ASN Kidney Week; Nov. 2-7, 2021 (virtual meeting).
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High-dose extended-release calcifediol was well tolerated in patients with stage 5 CKD
Published by:
Strugnell SA, et al. Abstract TH-OR19. Presented at: ASN Kidney Week; Nov. 2-7, 2021 (virtual meeting).
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For patients with stage 5 chronic kidney disease on hemodialysis, high-dose extended-release calcifediol was well tolerated and reduced intact parathyroid hormone levels, according to research presented at ASN Kidney Week.
The 900 mcg per week dose was capable of normalizing serum levels of 1,25-dihydroxyvitamin D, even in patients who lacked kidney function.
"Stabilization of [intact parathyroid hormone] iPTH was observed with [extended-release calcifediol] ERC vs. placebo, and significant decreases were observed with increased 25(OH)D exposure," Stephen A. Strugnell, PhD, senior director of scientific affairs at OPKO Health Inc., said during his presentation.
"Greater reductions of PTH may have been possible if better serum P control had been achieved during the treatment period," he said.
Researchers studied 44 adults from 27 U.S. dialysis centers who had been on hemodialysis for at least 6 months. Of the patients enrolled, 33 were in the high-dose ERC arm and 11 were in the placebo arm.
During the course of 8 weeks, substances such as vitamin D that could affect parathyroid hormone levels were washed out of patients' systems before they were randomized into 300 mcg of ERC treatment three times weekly or a similar placebo regimen.
Serum total 25(OH)D levels remained stable from baseline until conclusion of treatment, while serum rates in the ERC group increased to 160 ng/mL before leveling. The plateau occurred, on average, after 120 days, according to Strugnell.
“Mean PTH data recorded near the beginning, middle and end of treatment showed a continuous upward trend over time in the placebo group and a decrease after 3 months of treatment in the ERC group, followed by a return to near baseline levels by the end of treatment," Strugnell said.
Patients with lower body weight had significantly higher serum 25(OH)D levels and notably lower plasma iPTH rates, he said.
Serious adverse events were comparable between the ERC and placebo arms.
ERC was previously approved by the FDA for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 CKD.
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