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Abstract: FR-PO133

Effect of Switching from Cinacalcet to Etelcalcetide on Secondary Hyperparathyroidism in Patients with Hemodialysis: An ESCORT Trial

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Fukami, Kei, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
  • Kurokawa, Yuka, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
  • Yano, Junko, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
  • Kodama, Goh, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
  • Moriyama, Tomofumi, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
  • Nakayama, Yosuke, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
  • Kaida, Yusuke, Division of Nephrology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
Background

Cinacalcet (Cina) is used in the management of secondary hyperparathyroidism (SHPT) in patients undergoing hemodialysis (HD). Etelcalcetide (Etel) is a novel intravenous calcimimetic for the treatment of SHPT, which could improve drug adherence and reduce adverse gastrointestinal events. Here, we evaluated the efficacy of switching from Cina to Etel in the management of SHPT and constructed the dose conversion factor in this ESCORT trial.

Methods

A total of 138 HD patients on Cina were screened, and 93 patients with serum-intact parathyroid hormone (iPTH) ≥60 pg/mL and serum albumin-corrected calcium (cCa) ≥8.4 mg/dL were enrolled. The patients were divided into three groups (Cina 25 mg, 50 mg, and ≥75 mg). Etel was administered intravenously for 24 weeks. The primary endpoint was the dose distribution of Etel in patients who achieved target iPTH levels (60–240 pg/mL) after 24 weeks. Further, we investigated serum bone alkaline phosphatase (BAP), tartrate-resistant acid phosphatase 5b (TRACP 5b), and fibroblast growth factor 23 (FGF23).

Results

A total of 90 patients completed the study. At the end of the study, mean iPTH levels significantly decreased in the Cina 25 mg group (Cina 25 mg: from 179.8 ± 97.1 to 137.4 ± 62.9 pg/mL, p = 0.003; Cina 50 mg: from 177.0 ± 122.5 to 177.2 ± 80.3 pg/mL, p = 0.996; Cina ≥75 mg: from 289.4 ± 300.7 to 236.9 ± 211.6 pg/mL, p = 0.110). cCa levels significantly decreased (p < 0.001). Serum BAP, TRACP5b, and FGF23 levels also decreased following the drug switching (p = 0.001, p < 0.001, p = 0.009, respectively). Sixty patients (66.7%) maintained target iPTH levels before and after the study (pre: 133.5 ± 45.6 pg/ml; post: 148.2 ± 46.9 pg/ml). In these patients, the dose of Cina before the switch was 42.9 mg/day, and the final dose of Etel was 6.17 mg/HD. The dose conversion factor for the switch from Cina to Etel was 4.640 + 0.036*pre-dose (Cina/day). No adverse events, such as hypocalcemia and gastrointestinal symptoms, led to study discontinuation in this trial.

Conclusion

Switching from Cina to Etel effectively improved MBD and ameliorated high iPTH in patients undergoing HD for 24 weeks. No serious adverse events were observed. These results suggest beneficial effects of Etel administration in managing SHPT in patients undergoing HD.

Funding

  • Commercial Support