ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

ASN / Education & Meetings / Kidney Week /
Abstract: TH-PO1277

Efficacy and Safety of Gosicalcetide vs. Cinacalcet in Patients with Secondary Hyperparathyroidism Receiving Hemodialysis: Results from a Phase 3 Randomized Clinical Trial

Session Information

Category: Bone and Mineral Metabolism

  • 502 Bone and Mineral Metabolism: Clinical

Authors

  • Yu, Xueqing, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
  • Ye, Zhiming, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
  • Li, Sijia, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
  • Huang, Renwei, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
  • Fan, Li, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
  • Yang, Jing, Hefei First People's Hospital, Hefei, China
  • Liu, Aiying, Baotou Central Hospital, Baotou, China
  • Yang, Ming, Affiliated Hospital of Yangzhou University, Yangzhou, China
  • Chang, Wenxiu, Tianjin First Central Hospital, Tianjin, China
  • Liu, Shuxin, Dalian Municipal Central Hospital, Dalian, China
  • Zhang, Xin, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, China
  • Yang, Xue, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Lianyungang, China
  • Pan, Lili, Shanghai Hansoh BioMedical Co., Ltd., Shanghai, China
Background

Compared with oral calcimimetic treatment, intravenous (IV) administration could improve patient adherence and reduce adverse gastrointestinal (GI) effects. We assessed the efficacy and safety of gosicalcetide (HS-10568 or SHR6508), an IV calcimimetic, compared with oral calcimimetic cinacalcet.

Methods

In this double-blind, double-dummy, active-controlled, multicenter phase 3 trial (NCT06434961), participants (pts) receiving hemodialysis (HD) with secondary hyperparathyroidism (SHPT), intact PTH (iPTH) ≥400 pg/mL, and corrected calcium (cCa) ≥2.25 mmol/L were randomized 1:1 to gosicalcetide (starting dose 5 mg, dose range 2.5–20 mg) and cinacalcet (starting dose 25 mg, dose range 25–100 mg) groups. Primary endpoint was the percentage of pts achieving more than 30% iPTH reduction from baseline to Week 20–27, which was first tested for non-inferiority defined as the lower bound of 95% CI greater than -12%, and subsequently superiority if non-inferiority was established. Key secondary endpoint was the percentage of pts with ≥50% iPTH reduction compared to baseline.

Results

A total of 498 pts from 81 sites in China were randomized. Mean (SD) age was 49.7 (11.2) years, and 64.9% were male. Mean (SD) hemodialysis vintage was 8.1 (4.6) years and time from diagnosis of SHPT was 6.0 (3.9) years. Mean (SD) baseline iPTH was 828.95 (483.30) pg/mL. At Week 20–27, the difference in the percentages of pts achieving more than 30% iPTH reduction between gosicalcetide (90.2%; 95%CI, 86.3% to 94.1%) and cinacalcet (74.7%; 95%CI, 69.1% to 80.2%) was 15.5% (95% CI, 9.0% to 22%; P for superiority <0.0001). Both non-inferiority and superiority were demonstrated for the primary endpoint. The difference in the percentages of pts with ≥50% iPTH reduction between gosicalcetide (77.9%; 95%CI, 72.5% to 83.2%) and cinacalcet (50.5%; 95%CI, 44.1% to 56.8%) was 27.3% (95% CI, 19.1% to 35.5%; P<0.0001). The incidence of GI adverse event (AE) was significantly lower in gosicalcetide (50/248, 20.2%) than cinacalcet (72/250, 28.8%), with a difference of -8.7% (95% CI, -16.2% to -1.2%; P=0.0251).

Conclusion

In Chinese HD patients with SHPT, IV gosicalcetide demonstrated statistically superior and clinically meaningful reductions in iPTH compared with oral cinacalcet, with a significantly lower incidence of GI AEs.

Acknowledgment

This study was funded and sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Funding

  • Commercial Support – Jiangsu Hengrui Pharmaceuticals Co., Ltd.