A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2007

Last Updated Date

July 30, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic Study [ Time Frame: 44 hour interval ]

Original Primary Outcome Measures ^ICMJE

Pharmacokinetic Study

Change History

Complete list of historical versions of study NCT00454350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis

Official Title ^ICMJE

A Randomized , Open-Label, Cross-over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis

Brief Summary

This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Secondary Hyperparathyroidism

Intervention ^ICMJE

Drug: Hectorol (doxercalciferol injection)
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

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The subject must be receiving hemodialysis three times per week for a minimum of three months.
The subject must be receiving intravenous doxercalciferol or paricalcitol at each dialysis session (three times weekly) for a minimum of 12 weeks prior to Screening.
At Screening Visit the subject's laboratory measurements must be within the following ranges: Serum iPTH measurement between 150-800 pg/mL; Corrected calcium measurement ≤ 10.5 mg/dL; Serum phosphorus measurement ≤ 7 mg/dL

Exclusion Criteria:

Any ongoing use of over the counter or prescription vitamin D preparations except doxercalciferol or paricalcitol injection or multivitamins.
History of heparin-induced thrombocytopenia.

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

NCT00454350

Responsible Party

Medical Monitor, Genzyme Corporation

Study ID Numbers ^ICMJE

HECT00106

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