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

This study has been completed.

First Received: March 28, 2007 Last Updated: June 19, 2008 History of Changes

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 Zemplar® (paricalcitol injection).

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

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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

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:

Ajay Duggal, M.D.

Genzyme

More Information

Additional Information:

US FDA Approved Full Prescribing Information for Hectorol® Injection This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HECT00106
Study First Received:	March 28, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00454350 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Hectorol (doxercalciferol injection)
Zemplar (paricalcitol injection)

Study placed in the following topic categories:

Parathyroid Diseases
Ergocalciferol
Kidney Failure, Chronic
Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Trace Elements
Hyperparathyroidism, Secondary
1 alpha-hydroxyergocalciferol
Vitamin D

Vitamin D2
Hyperparathyroidism
Renal Insufficiency, Chronic
Vitamins
Neoplasm Metastasis
Calciferol
Micronutrients
Kidney Diseases
Endocrinopathy

Additional relevant MeSH terms:

Parathyroid Diseases
Hyperparathyroidism, Secondary
1 alpha-hydroxyergocalciferol
Hyperparathyroidism
Growth Substances
Vitamins

Physiological Effects of Drugs
Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009