HECT00106: A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis

This study is currently recruiting patients.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00454350

Purpose

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

Condition	Intervention	Phase
Secondary Hyperparathyroidism	Drug: Hectorol (doxercalciferol injection) Drug: Paricalcitol injection	Phase 4

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover

Assignment, Pharmacokinetics Study

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

Further Study Details:

Primary Outcome Measures: Pharmacokinetic Study

Expected Total Enrollment: 12

Study start: 2007-02

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 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.

Location and Contact Information

Minnesota
Minneapolis, Minnesota, United States; Recruiting

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

More Information

US FDA Approved Full Prescribing Information for Hectorol® Capsules

Study ID Numbers: HECT00106
ClinicalTrials.gov Identifier: NCT00454350
Health Authority: United States: Food and Drug Administration