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

This study has been completed.

First Received: April 18, 2007 Last Updated: July 30, 2009 History of Changes

Sponsor:	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

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.

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

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

U.S. FDA Resources

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:

Medical Monitor

Genzyme

More Information

Additional Information:

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

No publications provided

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

Keywords provided by Genzyme:

Hectorol (doxercalciferol capsules)
Zemplar (paricalcitol injection)

Additional relevant MeSH terms:

Parathyroid Diseases
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Hyperparathyroidism, Secondary

Neoplastic Processes
Neoplasms
Pathologic Processes
1 alpha-hydroxyergocalciferol
Hyperparathyroidism
Vitamins
Neoplasm Metastasis
Micronutrients

ClinicalTrials.gov processed this record on November 25, 2009