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

March 17, 2015 updated by: Genzyme, a Sanofi Company

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Downey, California, United States
      • Tarzana, California, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Texas
      • Houston, Texas, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject must be receiving hemodialysis three times per week for a minimum of six months.
  • The subject must have been receiving Hectorol Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
  • The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.

Exclusion Criteria:

  • In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
  • Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
  • The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
  • Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
  • Current use of aluminum or magnesium based binders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Hectorol capsules at 1.0 times current injection dose
Drug: Hectorol® (doxercalciferol capsules)
Hectorol capsules at 1.0 times current injection dose
Other: 2
Hectorol capsules at 1.5 times current injection dose
Drug: doxercalciferol capsules, Hectorol®
Hectorol capsules at 1.5 times current injection dose
Other: 3
Hectorol capsules at 2.0 times current injection dose
Drug: doxercalciferol capsules, Hectorol® capsules
Hectorol capsules at 2.0 times current injection dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Conversion
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HECT00406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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