PLS240 for Secondary Hyperparathyroidism

(PATH-1 Trial)

Recruiting in Palo Alto (17 mi)

+76 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pathalys Pharma

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Research Team

Eligibility Criteria

Adults aged 18-80 on hemodialysis for end-stage kidney disease with secondary hyperparathyroidism can join. They must have stable vitamin D, phosphate binder, and calcium supplement doses, agree to contraception if applicable, and not be in other studies. Excluded are those with primary hyperparathyroidism, recent heart issues or strokes, uncontrolled diabetes or hypertension, certain ECG abnormalities, recent serious infections like COVID-19, or a history of malignancy within the last two years.

Inclusion Criteria

Voluntarily given written informed consent to participate in this study

To be eligible for inclusion into the Open-Label Extension Phase of the study, participants must fulfill the additional following criteria at the time of entry into the Open-Label Extension Phase: Have successfully completed the course of treatment and final safety follow-up visit of the Double-Blind Phase, Voluntarily given written informed consent to participate in the Open-Label Extension Phase of the study, Prescribed hemodialysis for 3 times per week, Continue to meet Inclusion Criteria 9, 10, and 12

I have been taking the same dose of calcium supplements for the last 2 months.

Exclusion Criteria

You have important irregularities in your screening blood tests, as determined by the doctor in charge of the study.

I have not had a stroke in the last 6 months.

I am being treated for seizures or had a seizure in the last 3 months.

Treatment Details

Interventions

• Open-Label Extension PLS240 (Hormone Therapy)
• Placebo (Placebo)
• PLS240 (Calcimimetic Agent)

Trial Overview The trial tests PLS240's effectiveness and safety against placebo in patients undergoing hemodialysis due to severe kidney disease complicated by secondary hyperparathyroidism. It has a double-blind phase (27 weeks) followed by an open-label extension (26 weeks), where all receive PLS240. Participants will undergo regular blood tests, ECGs and physical exams.

Participant Groups

Group I: Open-Label Extension Phase PLS240 Experimental Treatment 1 Intervention

After completion of the Double-Blind Phase, all participants will have the opportunity to enroll in the 26 week Open-Label extension, where they will receive PLS240.

Group II: Double-Blind Phase PLS240 Experimental Treatment 1 Intervention

Group III: Double-Blind Phase Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pathalys Pharma

Lead Sponsor

Trials

2

Recruited

770+

Launch Therapeutics

Collaborator

Trials

2

Recruited

770+