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

Genzyme

Status and phase: Completed; Phase 4

Conditions: Secondary Hyperparathyroidism

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418600

HECT00406

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

1

Other group

Description:

Hectorol capsules at 1.0 times current injection dose

Treatment:

Drug: Hectorol® (doxercalciferol capsules)

2

Other group

Description:

Hectorol capsules at 1.5 times current injection dose

Treatment:

Drug: doxercalciferol capsules, Hectorol®

3

Other group

Description:

Hectorol capsules at 2.0 times current injection dose

Treatment:

Drug: doxercalciferol capsules, Hectorol® capsules