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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07890584
- Acronym / sponsor ID
- PLS-PED-CLIN-01
- Keywords
- Chronic Kidney Disease (CKD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Pathalys PharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 22 Feb 2032 (estimated)
- Study completion
- 22 Feb 2032 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PLS240, Combination Product: Standard of CareAdolescents 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. |
| Cohort 2 | Experimental | Drug: PLS240, Combination Product: Standard of CareChildren 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. |
| Control Group | Active comparator | Combination Product: Standard of CareParticipants will only receive standard of care |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLS240Also: upacicalcetIntravenous (IV) bolus injection three times a week (TIW) | Drug | Cohort 1, Cohort 2 |
| Standard of CareActive vitamin D sterols, calcium supplementation, and/or phosphate binders | Combination product | Cohort 1, Cohort 2, Control Group |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pathalys Clinical Trials (Please reach out by email, clinicaltrials@pathalys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.