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

Tracking Information

First Received Date ^ICMJE

April 18, 2007

Last Updated Date

July 30, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Dose Conversion [ Time Frame: 10 weeks ]

Original Primary Outcome Measures ^ICMJE

Dose Conversion

Change History

Complete list of historical versions of study NCT00463021 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Safety

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Secondary Hyperparathyroidism

Intervention ^ICMJE

Drug: Hectorol (doxercalciferol capsules)
Drug: Zemplar (paricalcitol injection)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00463021

Responsible Party

Medical Monitor, Genzyme Corporation

Study ID Numbers ^ICMJE

HECT00306

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP