PTH Attenuation Trial in Hemodialysis-2

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pathalys Pharma
• Collaborator: Launch Therapeutics

Criteria

Inclusion Criteria:

• Prescribed hemodialysis for 3 times per week and on therapy for at least 3 months

• Women who are not of child-bearing potential must commit to remain abstinent or are willing to use highly effective contraception during the study and for 2 weeks after the last dose of investigational product

• Women of child-bearing potential must have a negative serum pregnancy test

• Male participants must be willing to use highly effective contraception and not donate sperm during the treatment phase and for 2 weeks after the last dose of investigational product

• For Open-Label Extension only: Participants must have completed the final safety follow-up of the Double-Blind Phase

Exclusion Criteria:

• Diagnosis of primary hyperparathyroidism

• History of parathyroid intervention including parathyroidectomy (PTx) and percutaneous ethanol injection therapy (PEIT) within 26 weeks before screening

• Anticipated or scheduled parathyroidectomy during the study period

• Planned kidney transplant during the study period

• Noncompliant with hemodialysis (i.e., missing more than 2 sessions within 8 weeks prior to screening)

• Having been hospitalized, other than for dialysis, within 30 days before screening

• History of malignancy within the last 2 years prior to screening (except squamous or basal cell skin cancers, or cervical carcinoma in situ)

• History of myocardial infarction (heart attack), coronary angioplasty, or coronary arterial bypass grafting within the past 4 months prior to screening

• Stroke within 6 months before screening

• Pregnant or breast feeding

• Current, recent, or suspected infection within 4 weeks of screening of SARS-CoV-2/COVID-19