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

Secondary Hyperparathyroidism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463021
• Other study ID #: HECT00306
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2007
• Last updated: May 4, 2015
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Secondary Hyperparathyroidism

Intervention

Drug:
• Hectorol (doxercalciferol capsules)

• Zemplar (paricalcitol injection)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Conversion		10 weeks

External Links

•   US FDA Approved Full Prescribing Information for Hectorol® Capsules