Upacicalcet, a novel intravenous small molecule calcimimetic in late-stage development in Japan, may help control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis (HD). The new research findings were presented at Kidney 2020 Week Reimagined, a virtual meeting sponsored by the American Society of Nephrology.

In a phase 3, multicenter, double-blind trial, investigators randomly assigned 154 patients 2:1 to intravenous upacicalcet or placebo. Upacicalcet or placebo was administered thrice weekly at the end of each HD session at an initial dose of 25 or 50 mcg, then adjusted (up to 300 mcg) to maintain serum iPTH within the Japanese target range of 60 to 240 pg/mL.

Significantly more patients receiving upacicalcet than placebo achieved and maintained target-range iPTH: 67.0% vs 8.0% (P <.001), Tadao Akizawa, MD, of Showa University School of Medicine in Tokyo, Japan, and colleagues reported. The novel calcimimetic significantly reduced iPTH and corrected calcium levels, but not serum phosphorus.

Treatment-emergent adverse events (AEs) occurred in 85.4% of upacicalcet-treated patients and 72.0% of placebo recipients. AEs of the upper gastrointestinal (GI) tract occurred in 20.4% vs 18.0%, respectively. Neither group experienced hypocalcemia.


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UPA will be “a promising calcimimetic agent capable of safe and appropriate management of SHPT,” Dr Akizawa’s team stated. The drug significantly decreases iPTH without increasing upper GI symptoms.

Disclosure: This clinical trial was supported by Sanwa Kagaku Kenkyusho. Please see the original reference for a full list of authors’ disclosures.

Reference

Akizawa T, Honda D, Taniguchi M, Koiwa F. Efficacy and safety of upacicalcet in hemodialysis patients with secondary hyperparathyroidism: a phase 3 study. Presented at: Kidney Week 2020 Reimagined; October 19-25, 2020. Poster TH-OR20.