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

Secondary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454350
• Other study ID #: HECT00106
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: May 4, 2015
• Start date: February 2007
• Est. completion date: July 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Secondary Hyperparathyroidism

Intervention

Drug:
• Hectorol (doxercalciferol injection)

• 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	Pharmacokinetic Study		44 hour interval

External Links

•   US FDA Approved Full Prescribing Information for Hectorol® Injection