A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00418600
First received: January 3, 2007
Last updated: July 30, 2009
Last verified: December 2007
  Purpose

Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.


Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: Hectorol® (doxercalciferol capsules)
Drug: doxercalciferol capsules, Hectorol®
Drug: doxercalciferol capsules, Hectorol® capsules
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4, Multi-Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® Capsules When Converting From Hectorol® Injection for the Treatment of SHPT in Stage 5 CKD Subjects on Hemodialysis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Dose Conversion [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Hectorol capsules at 1.0 times current injection dose
Drug: Hectorol® (doxercalciferol capsules)
Hectorol capsules at 1.0 times current injection dose
2
Hectorol capsules at 1.5 times current injection dose
Drug: doxercalciferol capsules, Hectorol®
Hectorol capsules at 1.5 times current injection dose
3
Hectorol capsules at 2.0 times current injection dose
Drug: doxercalciferol capsules, Hectorol® capsules
Hectorol capsules at 2.0 times current injection dose

  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 six months.
  • The subject must have been receiving Hectorol Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
  • The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium < 10.0 mg/dL; phosphorus < 7.0 mg/dL.

Exclusion Criteria:

  • In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
  • Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
  • The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
  • Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
  • Current use of aluminum or magnesium based binders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418600

Locations
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Downey, California, United States
Tarzana, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Spokane, Washington, 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: NCT00418600     History of Changes
Other Study ID Numbers: HECT00406
Study First Received: January 3, 2007
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Secondary Hyperparathyroidism
Hectorol® (doxercalciferol capsules)
Hectorol® (doxercalciferol 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 September 22, 2014