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Kidney Week

Abstract: PO0565

Comparison of Extended-Release Calcifediol (ERC), Immediate-Release Calcifediol, Cholecalciferol, and Paricalcitol for Treating Secondary Hyperparathyroidism (SHPT) in CKD

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Strugnell, Stephen A., OPKO Health Inc., Miami, Florida, United States
  • Spiegel, David M., Vifor Pharma Ltd, Zurich, Switzerland
  • Csomor, Philipp, Vifor Pharma Ltd, Zurich, Switzerland
  • Ashfaq, Akhtar, OPKO Health Inc., Miami, Florida, United States
  • Bishop, Charles W., OPKO Health Inc., Miami, Florida, United States
Background

Serum total 25-hydroxyvitamin D (25D) levels above 50.8 ng/mL are required to produce meaningful and progressive reductions in plasma intact parathyroid hormone (iPTH) in patients with stages 3 or 4 CKD [Strugnell et al 2019]. The current study compared the abilities of four treatment regimens to increase serum 25D to this level and to reduce iPTH in this population.

Methods

Subjects with stage 3 or 4 CKD, SHPT (iPTH ≥85 and <500 pg/mL) and vitamin D insufficiency (25D <30 ng/mL) underwent an 8-week washout from previous vitamin D therapies and were randomized to 60 days of open-label treatment with: 1) ERC 60 mcg/day; 2) immediate-release calcifediol (IRC) 266 mcg/month; 3) high-dose cholecalciferol (HDC) 300,000 IU/month; or 4) paricalcitol plus low-dose cholecalciferol (PLDC) 1 mcg and 800 IU/day. Paricalcitol was increased to 2 mcg/day after 30 days if iPTH was not reduced by 30% and safety parameters allowed. Subjects were monitored for changes in serum 25D, calcium (Ca) and phosphorus (P), and plasma iPTH.

Results

Mean (SD) post-washout/pre-treatment baseline levels for 25D and iPTH in the per-protocol population were 20.6 (6.6) ng/mL and 145 (90) pg/mL, respectively. No differences were observed at baseline between treatment groups (14-17 subjects each). At the end of treatment, mean 25D (ng/mL) increased to 82.9 (17.0) with ERC (P<0.05), 30.8 (11.6) with HDC (P<0.05), 26.3 (6.8) with IRC and 24.2 (7.3) with PLDC. All subjects treated with ERC attained 25D levels ≥30 ng/mL vs. only 44% with HDC (P<0.001), 20% with IRC and 14% with PLDC. Most ERC subjects (94%) attained 25D levels >50.8 ng/mL. The proportion of subjects who achieved at least a 20% reduction in iPTH were 71% with ERC, 38% with HDC, 20% with IRC and 79% with PLDC. No changes from baseline were observed in mean Ca or P in any treatment group, but one instance of hypercalcemia (>10.3 mg/dL) was observed with PLDC treatment.

Conclusion

ERC was safe and more effective at increasing serum 25D and decreasing plasma iPTH than IRC, HDC or PLDC in patients with SHPT, vitamin D insufficiency, and stage 3 or 4 CKD.

Funding

  • Commercial Support