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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

NCT ID NCT07890584

NEW Sponsor: Pathalys Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 22, 2026 · Last updated Oct 22, 2026

Summary

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female participants age of \>1 month to \<18 years (Cohort 1: ≥13 to \<18 years, Cohort 2: \>1 month to \<13 years). 2. Dry weight ≥7 kg during screening. 3. Diagnosed with Chronic Kidney Disease (CKD) and secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis at the time of screening. Exclusion Criteria: 1. History of congenital long QT syndrome, second- or third-degree heart block, ventricular tachyarrhythmias, or other conditions associated with prolonged QT interval. 2. Anticipated parathyroidectomy during the study period. 3. Scheduled kidney transplant during the study period. 4. Participants received a parathyroidectomy within 6 months prior to randomization. 5. Receipt of cinacalcet therapy within 4 weeks prior to screening assessments and through randomization. 6. Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome secondary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease (CKD) Secondary hyperparathyroidism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site # 10103

    Buffalo, New York, 14203, United States

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