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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418600
First Posted: January 5, 2007
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism Drug: Hectorol® (doxercalciferol capsules) Drug: doxercalciferol capsules, Hectorol® Drug: doxercalciferol capsules, Hectorol® capsules Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose Conversion [ Time Frame: 5 weeks ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Hectorol capsules at 1.0 times current injection dose
Drug: Hectorol® (doxercalciferol capsules)
Hectorol capsules at 1.0 times current injection dose
2
Hectorol capsules at 1.5 times current injection dose
Drug: doxercalciferol capsules, Hectorol®
Hectorol capsules at 1.5 times current injection dose
3
Hectorol capsules at 2.0 times current injection dose
Drug: doxercalciferol capsules, Hectorol® capsules
Hectorol capsules at 2.0 times current injection dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418600


Locations
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Downey, California, United States
Tarzana, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00418600     History of Changes
Other Study ID Numbers: HECT00406
First Submitted: January 3, 2007
First Posted: January 5, 2007
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
Secondary Hyperparathyroidism
Hectorol® (doxercalciferol capsules)
Hectorol® (doxercalciferol injection)

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents