NCT05832931

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

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 Kidney Disease on Hemodialysis (PATH-1) With an Open-Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Pathalys Pharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

Conditions

• Secondary Hyperparathyroidism
• End-stage Kidney Disease (ESKD)

Interventions

Type	Name	Description
DRUG	PLS240	Participants will receive intravenous (IV) PLS240 three times per week for 27 weeks.
DRUG	Placebo	Participants will receive intravenous (IV) placebo, containing no active drug, three times per week for 27 weeks.
DRUG	Open-Label Extension PLS240	Participants will receive intravenous (IV) PLS240 three times per week for a maximum of 26 weeks.

Timeline

• Start date: 2023-04-28
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2023-04-27
• Last updated: 2025-09-09

Locations

68 sites across 6 countries: United States, Bulgaria, Poland, Portugal, Serbia, Spain

Regulatory

• FDA-regulated drug study