PLS240 for Secondary Hyperparathyroidism (PATH-2 Trial)

Palo Alto (17 mi)

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.

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

I am a man willing to use effective birth control and not donate sperm during and for 2 weeks after treatment.

I am on hemodialysis 3 times a week.

I am between 18 and 80 years old.

I have finished all treatments and safety checks from the earlier blind study phase.

Exclusion Criteria

I or my family have a history of long QT syndrome.

I am scheduled for a kidney transplant from a living donor during the study.

My blood pressure has been very high during dialysis sessions.

I have had heart rhythm problems or Torsade de Pointes.

I haven't had COVID-19 in the last 4 weeks.

I have been diagnosed with primary hyperparathyroidism.

My parathyroid hormone levels were above 1500 pg/mL at least twice before dialysis.

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

I am scheduled for or might have a parathyroid gland surgery.

I have severe heart failure.

Treatment Details

The trial tests PLS240's effectiveness and safety against a placebo in patients undergoing hemodialysis due to severe kidney disease causing high parathyroid hormone levels. It has two phases: a double-blind phase where participants get either PLS240 or placebo randomly for 27 weeks; followed by an open-label extension where all receive PLS240 for another 26 weeks.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label Extension Phase PLS240Experimental Treatment1 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 PLS240Experimental Treatment1 Intervention

Group III: Double-Blind Phase PlaceboPlacebo Group1 Intervention