A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

ClinicalTrials.gov ID: NCT00418600

Public ClinicalTrials.gov record NCT00418600. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.

Study identification

NCT ID: NCT00418600
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: Genzyme, a Sanofi Company; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Secondary Hyperparathyroidism

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 31, 2006
Primary completion: May 31, 2007
Completion: Jul 31, 2007
Last update posted: Mar 18, 2015

2006 – 2007

United States locations

U.S. sites: 8
U.S. states: 7
U.S. cities: 8

Facility	City	State	ZIP	Site status
Not listed	Hot Springs	Arkansas	—	—
Not listed	Downey	California	—	—
Not listed	Tarzana	California	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Cincinnati	Ohio	—	—
Not listed	Pittsburgh	Pennsylvania	—	—
Not listed	Houston	Texas	—	—
Not listed	Spokane	Washington	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00418600, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 18, 2015 · Synced Sep 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00418600 live on ClinicalTrials.gov.

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