Abstract: TH-PO1192
Extended-Release Calcifediol (ERC) for Secondary Hyperparathyroidism (SHPT) in Chinese Patients with Stages 3 and 4 CKD: A Phase 3 Trial
Session Information
- Late-Breaking Research Posters
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Fang, Ming, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
- Haoyan, Haoyan, Zigong First People’s Hospital, Zigong, Sichuan, China
- Mao, Huijuan, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
- Ren, Hong, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Lin, Hongli, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
- Li, Haiming, Nicoya Therapeutics (Shanghai) Co.,Ltd, Shanghai, China
Background
Vitamin D insufficiency (VDI) drives SHPT and is associated with multiple complications in CKD patients. ERC has been approved in the United States and Europe for the treatment of SHPT in adults with stage 3-4 CKD and VDI, but not in China. The present trial evaluated the efficacy and safety of ERC treatment in adult Chinese patients with SHPT, stage 3-4 CKD and VDI.
Methods
A randomized, double-blind, placebo-controlled phase 3 trial was conducted in 100 Chinese adults with estimated glomerular filtration rate (eGFR) ≥15 to <60 mL/min/1.73m^2, plasma intact parathyroid hormone (iPTH) ≥85 pg/mL and serum total 25-hydroxyvitamin D (25D) <30 ng/mL. Participants were randomized 2:1 to receive oral ERC (n=67) or placebo (n=33) once daily at bedtime for 26 weeks. Dosing started at 30 µg/d and increased, as needed, to 60 µg/d after 3 months. The primary efficacy endpoint was the proportion of participants attaining a mean decrease of ≥30% from baseline (BL) in iPTH in the efficacy assessment period (EAP), defined as the last 6 weeks of treatment. A secondary efficacy endpoint was the proportion of participants with serum 25D ≥30 ng/mL in the EAP. Safety endpoints included changes in serum calcium (Ca) and phosphorus (P), urine Ca:creatinine ratio (Ca:Cr) and treatment-emergent adverse events (TEAEs).
Results
Participants in the intent-to-treat (ITT) set had mean (SD) age 52.62±12 years, body mass index 24.5±4.2 kg/m2 and eGFR 24.1±8.0 mL/min/1.73m2, and were 17% stage 3 CKD and 49% female. BL demographics were comparable between treatment groups and across CKD stages. The proportion of participants with ≥30% reduction in iPTH from BL was higher (p<0.0001) with ERC than placebo (ITT: 53.0% vs 6.3%; per-protocol [PP]: 55.7% vs 7.4%). The proportion of participants with normal 25D (≥30 ng/mL) was also higher (p<0.0001) with ERC (ITT: 90.9% vs 9.4%; PP: 95.1% vs 11.1%). Mean serum Ca increased with ERC by 0.099 mg/dL and decreased with placebo by 0.160 mg/dL (p<0.005). ERC had inconsequential impact on mean urine Ca:Cr, serum P, eGFR and TEAEs. Two participants in the ERC group experienced hypercalcemia (>10.3 mg/dL). None experienced hypercalciuria (>0.2 Ca:Cr).
Conclusion
Oral ERC was effective and safe in treating SHPT in Chinese adults with stage 3 or 4 CKD and VDI.