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First received: April 18, 2023

Clinical Trial: Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2

Study Status: Completed

Recruit Status: RECRUITING

Condition: Secondary Hyperparathyroidism

Study Type: INTERVENTIONAL


Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals With End Stage

Brief Summary: This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT).The study consists of two phases.First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks.After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive…

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