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Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

NCT02859896 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-07-29

No results posted yet for this study

Summary

Primary Objective:

Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).

Secondary Objectives:

* Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules.
* Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

Conditions

  • Secondary Hyperparathyroidism-Chronic Kidney Disease

Interventions

DRUG

Doxercalciferol (GZ427397)

Pharmaceutical form: capsule Route of administration: oral

DRUG

Calcitriol

Pharmaceutical form: capsule Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-19
Primary Completion
2025-06-11
Completion
2025-06-11
FDA Drug
Yes

Countries

  • United States
  • Chile

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859896 on ClinicalTrials.gov