Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Randomized Placebo-Controlled Trial.

ABSTRACT:

Background

Secondary hyperparathyroidism is a major complication of patients undergoing hemodialysis (HD). Upacicalcet, a new injectable calcimimetic, acts on calcium-sensing receptors to suppress parathyroid hormone (PTH) secretion. We examined the efficacy and safety of upacicalcet in patients with secondary hyperparathyroidism receiving HD.

Methods

In this phase 3, double-blind, placebo-controlled study, we randomized Japanese patients undergoing HD with serum intact PTH (iPTH) concentrations >240 pg/ml and corrected calcium concentrations ≥8.4 mg/dl. Either upacicalcet or placebo was administered after each HD session for 24 weeks. The primary outcome was the percentage of participants achieving the target mean serum iPTH concentration (60-240 pg/ml) at weeks 22-24.

R

SUBMITTER: Shigematsu T 

PROVIDER: S-EPMC10578632 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature