PATH-2: PLS240

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

medical-cross
Hemodialysis access, Thyroid diseases
user
All genders
person-wave 18-80
world
Recruiting now
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Overview
Principal Investigator: Daniel Weiner MD., MS

This will be a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of PLS240 in eligible participants with ESKD and SHPT.

Study details
Inclusion Criteria
  • 1. Prescribed hemodialysis for 3 times per week and on therapy for at least 3 months and has a
    delivered Kt/V≥1.2 within 4 weeks prior to screening laboratory assessment
  • 2. Pre-dialysis central laboratory screening iPTH must be ≥450 pg/mL on two measurements
    performed at 2 visits at least 1 week apart. Only one (1) repeat iPTH is allowed and must be
    at least performed at least a week after the previous iPTH
  • 3. cCa before dialysis ≥8.4 mg/dL at the time of screening (may be repeated once)
Exclusion Criteria
  • 1. Diagnosis of primary hyperparathyroidism
  • 2. History of parathyroid intervention including parathyroidectomy (PTx) and percutaneous
    ethanol injection therapy (PEIT) within 26 weeks before screening
  • 3. Screening iPTH >1500 pg/mL
Study Requirements

During the double blind phase, there will be 19 study visits that will occure during dialysis that will be over the course of 27 weeks. The open label extension could be up to 28 weeks and visits would occur weekly. Blood draws will regularly occur.