A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
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Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
2actual
Sites
15
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Company Decision
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-16 | actual | When the study began enrolling |
| Primary completion | 2025-06-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-09 | actual | The whole study's end, after follow-up |
| First posted | 2019-08-22 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-15 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Chronic Kidney Disease (CKD)
- Secondary Hyperparathyroidism (SHPT)
Intervention
- Drug: Paricalcitol
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Who Achieve Positive Response During Dosing Period 1
measured Up to Week 12
Incidence of Hypercalcemia During Dosing Period 1
measured Up to Week 12
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-07-13 · 901 KB · Prot_000.pdf
Statistical Analysis Planposted 2025-11-07 · 544 KB · SAP_001.pdf
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