412 Participants Needed

PLS240 for Secondary Hyperparathyroidism

(PATH-2 Trial)

Recruiting at 75 trial locations
PC
Overseen ByPathalys Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pathalys Pharma
Must be taking: Vitamin D sterols
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Research on vitamin D analogues, like CTA018/MT2832, shows they can effectively lower parathyroid hormone levels without affecting calcium or phosphorus levels, suggesting potential benefits for secondary hyperparathyroidism treatment.12345

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

I am a woman who cannot become pregnant or will avoid pregnancy during the study.
Voluntarily given written informed consent to participate in this study
I am a man willing to use effective birth control and not donate sperm during and for 2 weeks after treatment.
See 13 more

Exclusion Criteria

Continues to meet Exclusion Criterion #5
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.
See 32 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Double-Blind Treatment

Participants are randomly assigned to receive dose-titrated PLS240 or placebo for 27 weeks

27 weeks
Multiple visits (in-person)

Open-Label Extension

Participants receive dose-titrated PLS240 for an additional 26 weeks

26 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • PLS240
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pathalys Pharma

Lead Sponsor

Trials
2
Recruited
770+

Launch Therapeutics

Collaborator

Trials
2
Recruited
770+

References

Determinants for serum 1,25-dihydroxycholecalciferol in primary hyperparathyroidism. [2019]
Vitamin D analogues targeting CYP24 in chronic kidney disease. [2016]
Fibroblast growth factor 23, parathyroid hormone, and 1alpha,25-dihydroxyvitamin D in surgically treated primary hyperparathyroidism. [2021]
FGF23 and primary hyperparathyroidism: is there a link? [2021]
Differential effects of 1,25-(OH)2D3 and 22-oxacalcitriol on phosphate and calcium metabolism. [2019]
Elevated FGF23 levels are associated with impaired calcium-mediated suppression of PTH in ESRD. [2021]
Serum fibroblast growth factor-23 levels predict the future refractory hyperparathyroidism in dialysis patients. [2021]
Fibroblast growth factor-23 in early chronic kidney disease: additional support in favor of a phosphate-centric paradigm for the pathogenesis of secondary hyperparathyroidism. [2021]
Molecular mechanisms of secondary hyperparathyroidism. [2019]
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