PLS240 for Secondary Hyperparathyroidism
(PATH-2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants stay on a stable dose of certain medications, like active Vitamin D sterols, phosphate binders, and calcium supplements, throughout the study. If you're taking these, you won't need to stop, but you must keep the dose stable.
What data supports the effectiveness of the drug PLS240 for treating secondary hyperparathyroidism?
How does the drug PLS240 differ from other treatments for secondary hyperparathyroidism?
PLS240 may be unique in its approach by potentially targeting fibroblast growth factor-23 (FGF23), which is involved in phosphate regulation and is linked to secondary hyperparathyroidism. This focus on FGF23 could offer a novel mechanism compared to traditional treatments that primarily address calcium and vitamin D levels.36789
What is the purpose of this trial?
This trial is testing a medication called PLS240 to help people with severe kidney disease who are on dialysis and have a related gland problem. The study will check if PLS240 can safely manage their condition by controlling certain hormones and minerals in their blood. Patients will be monitored over time.
Eligibility Criteria
Adults aged 18-80 on hemodialysis for end-stage kidney disease with secondary hyperparathyroidism can join. They must have specific levels of parathyroid hormone and calcium, stable doses of certain medications, and agree to contraception if applicable. Excluded are those with primary hyperparathyroidism, recent heart issues or seizures, certain cancers within the last two years, uncontrolled diabetes or hypertension, and anyone who's been in other drug trials recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-Blind Treatment
Participants are randomly assigned to receive dose-titrated PLS240 or placebo for 27 weeks
Open-Label Extension
Participants receive dose-titrated PLS240 for an additional 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- PLS240
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pathalys Pharma
Lead Sponsor
Launch Therapeutics
Collaborator