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

Completed · Phase 4

Conditions studied: Secondary Hyperparathyroidism

In brief

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).

Key facts

Study ID

NCT00454350

Run by

Genzyme, a Sanofi Company

People needed

12

Starts

2007-02-01

Expected to finish

2007-07-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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