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

Sponsor:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00418600

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Further study details as provided by Genzyme:

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

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

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

Additional Information:

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

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

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	HECT00406
Study First Received:	January 3, 2007
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00418600 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Secondary Hyperparathyroidism
Hectorol® (doxercalciferol capsules)
Hectorol® (doxercalciferol injection)

Additional relevant MeSH terms:

Parathyroid Diseases
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Hyperparathyroidism, Secondary

Neoplastic Processes
Neoplasms
Pathologic Processes
1 alpha-hydroxyergocalciferol
Hyperparathyroidism
Vitamins
Neoplasm Metastasis
Micronutrients

ClinicalTrials.gov processed this record on November 09, 2009