NCT00792857

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

Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: OPKO IP Holdings II, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Secondary Hyperparathyroidism
• Chronic Renal Insufficiency
• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	CTAP201 Injection	Comparison of different dose strengths of CTAP201 after single dose.
DRUG	Doxercalciferol	Comparison of different dose strengths of doxercalciferol after single dose.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2008-11-18
• Last updated: 2014-09-29

Locations

6 sites across 1 country: United States