NCT00123461

Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.

Conditions

• Secondary Hyperparathyroidism
• Renal Failure
• Chronic Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Hectorol (doxercalciferol capsules), 0.5mcg

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-07-25
• Last updated: 2015-05-05

Locations

19 sites across 2 countries: United States, Puerto Rico