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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00463021
First received: April 18, 2007
Last updated: July 30, 2009
Last verified: December 2007
  Purpose

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 Intervention Phase
Secondary Hyperparathyroidism
Drug: Hectorol (doxercalciferol capsules)
Drug: Zemplar (paricalcitol injection)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

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

Estimated Enrollment: 36
Study Start Date: April 2007
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463021

Locations
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
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00463021     History of Changes
Other Study ID Numbers: HECT00306
Study First Received: April 18, 2007
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Hectorol (doxercalciferol capsules)
Zemplar (paricalcitol injection)

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplasm Metastasis
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
1 alpha-hydroxyergocalciferol
Ergocalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014