A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Condition(s) studied

Investigational drug(s) / intervention(s)

PLS240: Intravenous (IV) bolus injection three times a week (TIW)

Standard of Care: Active vitamin D sterols, calcium supplementation, and/or phosphate binders

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of treatment-emergent adverse events (TEAEs). — From the first dialysis session after randomization and up to 28 days after the last administration of study medication for participants receiving PLS240 and up to Week 32 for participants in the control group.

Trial sites (1)

Other trials for the same condition