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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Secondary Hyperparathyroidism

Intervention: Hectorol® (doxercalciferol capsules) (Drug); doxercalciferol capsules, Hectorol® (Drug); doxercalciferol capsules, Hectorol® capsules (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Dose Conversion

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Hot Springs, Arkansas, United States

Downey, California, United States

Tarzana, California, United States

Atlanta, Georgia, United States

Cincinnati, Ohio, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Spokane, Washington, United States

Additional Information

Starting date: November 2006
Last updated: March 17, 2015

Page last updated: August 23, 2015

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