drugset / Trial / NCT00792857

Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

NCT00792857

Phase 1 Completed 24 enrolled OPKO IP Holdings II, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.

Timeline

Start
2008-11
Primary completion
2009-09
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CTAP201 Unknown Intravenous
Comparator Doxercalciferol Small molecule