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NCT00418600 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Secondary Hyperparathyroidism, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
36
Enrollment target
8
Study locations

NCT00418600 is a Phase 4 study of Secondary Hyperparathyroidism that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 36 participants, below the 60-participant average among 8 other Secondary Hyperparathyroidism trials with a reported enrollment target (40% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT00418600, a Phase 4 study of Secondary Hyperparathyroidism, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
36 participants
Enrollment target
8
Study locations

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.

Conditions Studied

Secondary Hyperparathyroidism

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

196 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, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 60-participant average among 8 other Secondary Hyperparathyroidism trials with a reported enrollment target (40% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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.

NCT00418600 reports 8 study locations spanning 7 distinct geographic areas - top geographies include California, Arkansas, Georgia.

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.

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).

Who is sponsoring clinical trial NCT00418600?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.