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Not yet recruiting Phase 3 Interventional

A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

ClinicalTrials.gov ID: NCT07890584

Public ClinicalTrials.gov record NCT07890584. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-label, Controlled, Multiple Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of PLS240 in Pediatric Participants 1 Month to <18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Approximately 56 participants who are 1 month old to 17 years old will be enrolled in this study. The total duration for this study will be 38 weeks (or up to 42 weeks when participants require a washout period due to prior exposure to prohibited medications) and includes the following periods: * Active screening period of 6 weeks (or, up to 10 weeks for participants requiring a washout period). * Treatment period of 28 weeks consisting of a 19-week dose titration period and 9-week stable dose period. * Safety follow-up period of 4 weeks.

Study identification

NCT ID
NCT07890584
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pathalys Pharma
Industry
Enrollment
56 participants

Conditions and interventions

Interventions

Drug · Combination Product

Eligibility (public fields only)

Age range
1 Month to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 30, 2026 (Estimated)
Primary completion
Feb 22, 2032 (Estimated)
Completion
Feb 22, 2032 (Estimated)
Last update posted
Oct 22, 2026

2026 – 2032

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Site # 10103 Buffalo New York 14203 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07890584, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 22, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07890584 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →