NCT07890584Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 22 Feb 2032
- Lead sponsor
- Pathalys Pharma
- Diseases
- Chronic kidney disease
- NCT number
- NCT07890584
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 56
- From 30 Oct 2026 to the primary completion date, 22 Feb 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled kidney transplant during the study period.
- Participants received a parathyroidectomy within 6 months prior to randomization.
- Receipt of cinacalcet therapy within 4 weeks prior to screening assessments and through randomization.
- Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.
Lab values
- History of congenital long QT syndrome, second- or third-degree heart block, ventricular tachyarrhythmias, or other conditions associated with prolonged QT interval.
Other
- Anticipated parathyroidectomy during the study period.
Who the study is looking for
- Male or female participants age of \>1 month to \<18 years (Cohort 1: ≥13 to \<18 years, Cohort 2: \>1 month to \<13 years).
- Dry weight ≥7 kg during screening.
- Diagnosed with Chronic Kidney Disease (CKD) and secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis at the time of screening.
Age in the registry: 1 month to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.