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

This study has been completed.

First Received on March 28, 2007. Last Updated on July 30, 2009 History of Changes

Sponsor:	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 Zemplar® (paricalcitol injection).

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

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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

Pharmacokinetic Study [ Time Frame: 44 hour interval ]

Estimated Enrollment:	12
Study Start Date:	February 2007
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454350

Locations

United States, Minnesota

Minneapolis, Minnesota, United States

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00454350 History of Changes
Other Study ID Numbers:	HECT00106
Study First Received:	March 28, 2007
Last Updated:	July 30, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Hectorol (doxercalciferol injection)
Zemplar (paricalcitol injection)

Additional relevant MeSH terms:

Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols

Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 09, 2012