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COMPLETED Phase 4

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

NCT00418600 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Hectorol® (doxercalciferol capsules)
  • DRUG doxercalciferol capsules, Hectorol®
  • DRUG doxercalciferol capsules, Hectorol® capsules

Study Locations (8)

California

  • — Downey
  • — Tarzana

Arkansas

  • — Hot Springs

Georgia

  • — Atlanta

Ohio

  • — Cincinnati

Pennsylvania

  • — Pittsburgh

Texas

  • — Houston

Washington

  • — Spokane

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-11
Est. Completion 2007-08
Phase Phase 4

Sponsor

Genzyme, a Sanofi Company

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00418600

The ClinicalTrials.gov registry entry for NCT00418600 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Secondary Hyperparathyroidism appearing as the primary indexed condition, and to 3 interventions — of which Hectorol® (doxercalciferol capsules) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00418600 reports 8 study locations spanning 7 distinct geographic areas — top geographies include California, Arkansas, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00418600 about?

NCT00418600 is a clinical study titled "A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis". 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 S...

What is the current status of trial NCT00418600?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2006-11. Estimated completion is 2007-08.

What conditions does trial NCT00418600 study?

This clinical trial studies the following conditions: Secondary Hyperparathyroidism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00418600?

The interventions under investigation include: Hectorol® (doxercalciferol capsules) (DRUG), doxercalciferol capsules, Hectorol® (DRUG), doxercalciferol capsules, Hectorol® capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00418600?

This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00418600 being conducted?

This trial has 8 study locations across Arkansas, California, Georgia, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial