Tests PLS240 in children with kidney disease and high parathyroid hormone on dialysis
Tests PLS240 in children on dialysis with kidney disease and high parathyroid hormone.
Plain-language title generated from the registry record
Registry title: A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Key facts
- Where
- Buffalo, United StatesSee the site
- Phase
- Phase 3
Where in United States
- BuffaloBuffalo, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pathalys Pharma
- Trial code
- NCT07890584
- Record updated
- 22 October 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; History of congenital long QT syndrome, second- or third-degree heart block, ventricular tachyarrhythmias, or other conditions associated with prolonged QT interval; Anticipated parathyroidectomy during the study period.