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Abstract: TH-PO1189

Effect of Etelcalcetide in Patients on Hemodialysis with Secondary Hyperparathyroidism: The DUET Trial

Session Information

Category: Bone and Mineral Metabolism

Authors

  • Itano, Yuya, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • Kato, Sawako, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • Kasuga, Hirotake, Nagoya Kyoritsu Hospital, Nagoya, Japan
  • Tsuboi, Masato, Anjo Kyoritsu Clinic, Anjo, Japan
  • Kuro-o, Makoto, Jichi Medical University, Shimotsuke, Japan
  • Kuwatsuka, Yachiyo, Nagoya University, Nagoya, Japan
  • Ando, Masahiko, Nagoya University, Nagoya, Japan
  • Maruyama, Shoichi, Nagoya University Graduate School of Medicine, Nagoya, Japan
Background

Etelcalcetide is a second-generation calcimimetic agent approved for treatment of Secondary Hyperparathyroidism (SHPT). The DUET trial (jRCTs041180108) was designed to clarify the efficacy of etelcalcetide, and to identify sensitive markers for vascular calcification.

Methods

The DUET study was a 12-week multicenter, open-label, randomized (1:1:1), parallel-group study in SHPT patients undergoing maintenance hemodialysis. Patients were randomly assigned to etelcalcetide + active vitamin D (Group E+D), etelcalcetide + oral calcium preparation (Group E+Ca), or control groups (Group C). The primary end point was to compare the proportion of patients with a 50% reduction from baseline in intact parathyroid hormone (iPTH) levels and iPTH levels ≤240 pg/mL at the 12-week time point after the trial start. Secondary end points included to compare changes in calciprotein particles (CPPs) and fibroblast growth factor 23 (FGF23).

Results

A total 124 patients (men 67.6%, 66.6 years) were randomized in this trial. The achievement proportion (95% confidential interval: CI) of the primary end point (iPTH 50% reduction and iPTH ≤240 pg/mL) were 90.0% (76.3-97.2) in Group E+D, 56.8% (39.5-72.9) in Group E+Ca, and 19.5% (8.8-34.9) in Group C, respectively. When compared the achievement proportion of the primary end point between the groups treated with etelcalcetide and the control groups by logistic regression analysis with iPTH, corrected serum calcium and phosphate at baseline as covariates, treatment of etelcalcetide demonstrated significant increase in achievement proportion (odds ratio 13.4; CI 5.10-35.3, P = 0.000). Next, when compared between Group E+D and Group E+Ca, achievement proportion in Group E+Ca was significantly inferior to that in Group E+D (odds ratio 0.16; CI 0.04-0.56, P = 0.004). The decrease in CPPs was estimated -59949 (AU) in patients treated with etelcalcetide and -37584 (AU) in controls in a linear mixed model, respectively. Similarly, the decrease in FGF23 was estimated -3044.9 (pg/mL) and -186.4 (pg/mL). However, the both decrease in CPPs and FGF23 could not reach significant differences between two groups by Tukey-Kramer multiple-comparison test.

Conclusion

Among maintenance hemodialysis patients with SHPT, the use of etelcalcetide showed good control of iPTH.

Funding

  • Commercial Support