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A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Sponsor: Pathalys Pharma
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.
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
Key Details
Gender
All
Age Range
1 Month - 17 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-10-30
Completion Date
2032-02-22
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
PLS240
Intravenous (IV) bolus injection three times a week (TIW)
Standard of Care
Active vitamin D sterols, calcium supplementation, and/or phosphate binders
Locations (1)
Site # 10103
Buffalo, New York, United States