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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05836220
Study type Interventional
Source Pathalys Pharma
Contact Pathalys Clinical Trials
Phone Please reach out by email
Email clinicaltrials@pathalys.com
Status Recruiting
Phase Phase 3
Start date May 15, 2023
Completion date May 2025

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