HECT00306: A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection

This study is currently recruiting patients.

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 4

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group 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:
Primary Outcomes: Dose Conversion

Secondary Outcomes: Safety

Expected Total Enrollment: 50

Study start: 2007-04

Eligibility

Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: Both

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.

Location and Contact Information

Medical Information 800-745-4447 medinfo@genzyme.com
Medical Information 617-252-7832 medinfo@genzyme.com

United States, Georgia
Decatur, Georgia, United States; Recruiting
Augusta, Georgia, United States; Recruiting

United States, Pennsylvania
Pittsburgh, Pennsylvania, United States; Recruiting

United States, Virginia
Norfolk, Virginia, United States; Recruiting

More Information

US FDA Approved Full Prescribing Information for Hectorol® Capsules

Study ID Numbers HECT00306
ClinicalTrials.gov Identifier NCT00463021
Health Authority: United States: Food and Drug Administration