Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

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 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.

Condition or disease

Secondary Hyperparathyroidism End-stage Kidney Disease (ESKD)
Drug: PLS240 Drug: Placebo Drug: Open-Label Extension PLS240
Phase 3

Source: View full study details on

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 7, 2023Comments | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine