A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

Secondary Hyperparathyroidism Clinical Trial

Official title:

A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418600
• Other study ID #: HECT00406
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2007
• Last updated: March 17, 2015
• Start date: November 2006
• Est. completion date: August 2007

Study information

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

Clinical Trial Summary

Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2007
• Est. primary completion date: June 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 Hectorol 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.

• Current use of aluminum or magnesium based binders.

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)
Hectorol capsules at 1.0 times current injection dose
• doxercalciferol capsules, Hectorol®
Hectorol capsules at 1.5 times current injection dose
• doxercalciferol capsules, Hectorol® capsules
Hectorol capsules at 2.0 times current injection dose

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		5 weeks	No

External Links

•   US FDA Approved Full Prescribing Information for Hectorol® Capsules
•   US FDA Approved Full Prescribing Information for Hectorol® Injection