PLS240

DRUG4 trials

Sponsors

Pathalys Pharma Inc., Pathalys Pharma

Conditions

ESKD participants with history of secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysisEnd Stage Kidney DiseaseEnd-stage Kidney Disease (ESKD)Secondary Hyperparathyroidism

Phase 3

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

CompletedNCT05832931

Pathalys PharmaEnd-stage Kidney Disease (ESKD), Secondary Hyperparathyroidism

Start: 2023-04-28End: 2025-07-28Updated: 2025-09-09

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2

CompletedNCT05836220

Pathalys PharmaEnd Stage Kidney Disease, Secondary Hyperparathyroidism

Start: 2023-05-15End: 2025-08-05Updated: 2025-09-09

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

CompletedCTIS2023-504338-24-00

Pathalys Pharma Inc.ESKD participants with history of secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis

Start: 2023-11-09End: 2025-06-26Target: 120Updated: 2025-06-16

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-2) With an Open-Label Extension

CompletedCTIS2023-504339-41-00

Pathalys Pharma Inc.ESKD participants with history of secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis

Start: 2023-11-08End: 2025-06-30Target: 100Updated: 2025-06-16