drugset / Trial / NCT00123461

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

NCT00123461

Phase 4 Completed 70 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-07
Primary completion
2007-10
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxercalciferol Small molecule 0.5 ug