PLS240 for Secondary Hyperparathyroidism
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for children and teens (1 month to 17 years old) with chronic kidney disease who are on hemodialysis and have secondary hyperparathyroidism. Participants may need to stop certain medications before joining.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- PLS240
Trial Overview
The study compares a new drug called PLS240 with standard treatments in young patients. Participants will be randomly assigned to receive either PLS240 or the usual care, and their progress will be monitored over about 38 weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Children aged 1 month to \<13 years. Once safety and Pharmacokinetic (PK)/Pharmacodynamic (PD) data from 15 evaluable participants from Cohort 1 have been reviewed by a Safety Review Committee (SRC), recruitment into the younger (infants, toddlers, and children) age group will commence. Participants will receive PLS240 plus standard of care.
Adolescents aged ≥13 to \<18 years. The study will initially only recruit participants into the older age group (Cohort 1). Participants will receive PLS240 plus standard of care.
Participants will only receive standard of care
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Who Is Running the Clinical Trial?
Pathalys Pharma
Lead Sponsor
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