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- Title
Phase 2 study of upacicalcet in Japanese haemodialysis patients with secondary hyperparathyroidism: an intraindividual dose-adjustment study.
- Authors
Inaguma, Daijo; Koiwa, Fumihiko; Tokumoto, Masanori; Fukagawa, Masafumi; Yoneda, Shinji; Yasuzawa, Hisami; Asano, Kenji; Hagita, Keiko; Inagaki, Yosuke; Honda, Daisuke; Akizawa, Tadao
- Abstract
Background Upacicalcet is a novel small-molecule calcimimetic agent developed for intravenous injection. Here, we evaluated the long-term efficacy and safety of upacicalcet treatment via intraindividual dose adjustment in haemodialysis patients with secondary hyperparathyroidism (SHPT). Methods A phase 2, multicentre, open-label, single-arm study was conducted. Upacicalcet was administered for 52 weeks; the starting dose was 50 μg thrice a week, and then adjusted to 25, 50, 100, 150, 200, 250, or 300 μg, according to the dose-adjustment method set in the protocol. The primary endpoint was the percentage of patients with serum intact parathyroid hormone (iPTH) level achieving a target range of 60–240 pg/mL (target achievement rate) at week 18. Results A total of 58 patients were administered upacicalcet. The target achievement rate of serum iPTH level at week 18 was 57.9%, which increased to 80.8% at week 52. The serum-corrected calcium (cCa) level decreased immediately after upacicalcet administration, but no further decrease was observed. Adverse events were observed in 94.8% of patients, and adverse drug reactions (ADRs) occurred in 20.7% of patients. The most common ADR was decreased adjusted calcium in eight patients; dizziness occurred as a serious ADR in one patient. The serum cCa level of patients who interrupted upacicalcet treatment at a serum cCa level of <7.5 mg/dL recovered to ≥7.5 mg/dL immediately after the interruption. Conclusions In haemodialysis patients with SHPT, upacicalcet doses of 25–300 μg for 52 weeks were found to be highly effective and well-tolerated, with minor safety concerns.
- Subjects
HEMODIALYSIS patients; DRUG side effects; HYPERPARATHYROIDISM; INTRAVENOUS injections; EDUCATIONAL attainment
- Publication
Clinical Kidney Journal, 2023, Vol 16, Issue 12, p2614
- ISSN
2048-8505
- Publication type
Article
- DOI
10.1093/ckj/sfad213