Working… Menu

A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

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. Identifier: NCT00463021
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : May 5, 2015
Information provided by:

Brief Summary:
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: Hectorol (doxercalciferol capsules) Drug: Zemplar (paricalcitol injection) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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® (Doxercalciferol Capsules) When Converting From Zemplar® (Paricalcitol Injection) for the Treatment of Secondary Hyperparathyroidism in Stage 5 Chronic Kidney Disease (CKD) Subjects on Hemodialysis.
Study Start Date : April 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Dose Conversion [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject must be receiving hemodialysis three times per week for a minimum of six months.
  • The subject must have been receiving Zemplar 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.

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 identifier (NCT number): NCT00463021

Layout table for location information
United States, California
Downey, California, United States
Paramount, California, United States
United States, Florida
Hudson, Florida, United States
United States, Georgia
Augusta, Georgia, United States
Decatur, Georgia, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Layout table for investigator information
Study Director: Medical Monitor Genzyme, a Sanofi Company
Additional Information:
Layout table for additonal information
Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00463021    
Other Study ID Numbers: HECT00306
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Keywords provided by Sanofi:
Hectorol (doxercalciferol capsules)
Zemplar (paricalcitol injection)
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Hyperparathyroidism, Secondary
Neoplastic Processes
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
1 alpha-hydroxyergocalciferol
Physiological Effects of Drugs
Bone Density Conservation Agents