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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00454350
First received: March 28, 2007
Last updated: July 30, 2009
Last verified: December 2007
  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 4

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:


Further study details as provided by Genzyme, a Sanofi Company:

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, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  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, a Sanofi Company:
Hectorol (doxercalciferol injection)
Zemplar (paricalcitol injection)

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Parathyroid Diseases
Endocrine System Diseases
Renal Insufficiency
Kidney Diseases
Urologic 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 April 14, 2014