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

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00463021

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 IV

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Genzyme:

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

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

Decatur, Georgia, United States

Augusta, 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

Investigators

Study Director:

Ajay Duggal, M.D.

Genzyme

More Information

US FDA Approved Full Prescribing Information for Hectorol® Capsules This link exits the ClinicalTrials.gov site

Study ID Numbers:	HECT00306
Study First Received:	April 18, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00463021
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Hectorol (doxercalciferol capsules)
Zemplar (paricalcitol injection)

Study placed in the following topic categories:

Parathyroid Diseases
Hyperparathyroidism, Secondary
Vitamin D
1 alpha-hydroxyergocalciferol
Hyperparathyroidism
Renal Insufficiency, Chronic

Ergocalciferols
Kidney Failure, Chronic
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy
Kidney Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Growth Substances
Vitamins

Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009