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Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

NCT05832931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Secondary Hyperparathyroidism
  • End-stage Kidney Disease (ESKD)

Interventions

DRUG

PLS240

Participants will receive intravenous (IV) PLS240 three times per week for 27 weeks.

DRUG

Placebo

Participants will receive intravenous (IV) placebo, containing no active drug, three times per week for 27 weeks.

DRUG

Open-Label Extension PLS240

Participants will receive intravenous (IV) PLS240 three times per week for a maximum of 26 weeks.

Sponsors & Collaborators

  • Launch Therapeutics

    collaborator UNKNOWN

  • Pathalys Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2025-07-28
Completion
2025-07-28
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Poland
  • Portugal
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832931 on ClinicalTrials.gov