A Phase 3 interventional study of PLS240 and Standard of Care in Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism, sponsored by Pathalys Pharma. Not yet recruiting at 1 site in United States. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Pathalys Pharma · Phase 3, Interventional, and Treatment
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:
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's planned enrollment of 56 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Pathalys Pharma is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Drug: PLS240 · Combination Product: Standard of Care
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.
Drug: PLS240 · Combination Product: Standard of Care
Participants will only receive standard of care
Combination Product: Standard of Care
Intravenous (IV) bolus injection three times a week (TIW)
Also known as: upacicalcet
Active vitamin D sterols, calcium supplementation, and/or phosphate binders
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: 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.
Change from baseline in intact parathyroid hormone (iPTH) over time
Time frame: Baseline through the End of Study visit [Study Week 32 + 7 days]
Concentration of upacicalcet in plasma at Weeks 2, 16, and 26.
Time frame: Week 2 (post-dialysis/pre-dose and 10 to 30 minutes post-dose), Week 16 (pre-dialysis and post-dialysis/pre-dose), and Week 26 (post-dialysis/pre-dose, and 10 to 30 minutes post-dose).
Removal rate of upacicalcet by dialysis
Time frame: Week 16 (pre-dialysis and post-dialysis/pre-dose)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Upacicalcet sodium hydrate
Renal Insufficiency, Chronic →
Pathalys Pharma