Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
21actual
Sites
23
Countries
Chile, 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
The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.
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 | 2017-01-19 | actual | When the study began enrolling |
| Primary completion | 2025-06-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-11 | actual | The whole study's end, after follow-up |
| First posted | 2016-08-09 | estimated | When this record first appeared on the registry |
| Results posted | 2026-07-02 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Secondary Hyperparathyroidism-Chronic Kidney Disease
Interventions
- Drug: Doxercalciferol (GZ427397) — also filed as Hectorol
- Drug: Calcitriol — also filed as Rocaltrol
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12
measured Baseline (Day 1) up to Week 12
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-07-15 · 864 KB · Prot_000.pdf
Statistical Analysis Planposted 2022-09-13 · 418 KB · SAP_001.pdf
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