Chronic Kidney Disease (CKD)Phase 3NCT07890584
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
A Phase 3 study testing PLS240 in people with Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism, run by Pathalys Pharma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
- What is being tested?
- PLS240
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 22 Feb 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- PLS240, Standard of Care
- Keywords
- Chronic Kidney Disease (CKD)
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLS240Drug
Also called upacicalcet
Intravenous (IV) bolus injection three times a week (TIW)
Standard of CareCombination product
Active vitamin D sterols, calcium supplementation, and/or phosphate binders
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: PLS240; Combination Product: Standard of Care |
| Cohort 2 | Experimental | 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. Receives: Drug: PLS240; Combination Product: Standard of Care |
| Control Group | Active comparator | Participants will only receive standard of care Receives: Combination Product: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs).
Measured: 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.
Secondary outcomes (3)
Change from baseline in intact parathyroid hormone (iPTH) over time
Measured: Baseline through the End of Study visit [Study Week 32 + 7 days]
Concentration of upacicalcet in plasma at Weeks 2, 16, and 26.
Measured: 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
Measured: Week 16 (pre-dialysis and post-dialysis/pre-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion22 Feb 2032 (estimated)
- Study completion22 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pathalys Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890584
- Sponsor's protocol ID
- PLS-PED-CLIN-01
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No