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Kidney Week

Abstract: TH-OR20

Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Phase 3 Study

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical


  • Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
  • Honda, Daisuke, Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan
  • Taniguchi, Masaki, Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan
  • Koiwa, Fumihiko, Showa University Fujigaoka Hospital, Yokohama, Japan

Secondary hyperparathyroidism (SHPT) is a major complication of hemodialysis (HD) patients. Calcimimetics suppress the hyperfunction of parathyroid and reduce serum calcium and phosphorus levels, and are currently used for the treatment of SHPT.
Upacicalcet (UPA) is a novel intravenous small molecule calcimimetic in late-stage development in Japan to treat SHPT of HD patients. We report the efficacy and safety of UPA in HD patients.


This study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. UPA or placebo (PBO) was administered t.i.w. at the end of HD at an initial dose of 50 mcg or 25 mcg. The doses were subsequently adjusted to maintain serum intact PTH (iPTH) levels between 60-240pg/ml (recommended level of Japanese guideline) every 3 weeks between 25 and 300 mcg during 24 weeks of treatment. The primary endpoint was the percentage of patients who achieved a mean iPTH level of 60–240 pg/ml in weeks 22 to 24.


A total of 154 SHPT patients were enrolled, and randomly allocated to UPA group (n: 103) or PBO group (n: 51).
The primary endpoint, percentage of patients achieving the target iPTH range was greater for UPA (67.0%) than for PBO (8.0%) (P<0.001). UPA significantly reduced iPTH and cCa levels compared with PBO (Fig.). Concerning phosphorus, no statistically significant difference between the groups was observed while it tended to decrease in the UPA group.
In the safety assessment, treatment emergent adverse events (AE) occurred in 88 patients (85.4%) and 36 patients (72.0%) in the UPA and the PBO groups. The incidences of upper-gastrointestinal-related AE were 20.4% in the UPA and 18.0% in the PBO groups (P=0.8298). As an AE, hypocalcemia did not occur in either group.


This study demonstrates that UPA significantly decreases iPTH without increasing the incidence of upper-gastrointestinal symptoms as compared to PBO.
It is suggested that UPA will be a promising calcimimetic agent capable of safe and appropriate management of SHPT.


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