Spots Global Cancer Trial Database for Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
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Trial Identification
Brief Title: Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Official Title: 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
Study ID: NCT00792857
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pivotal Reseach Centers, Peoria, Arizona, United States
Western New England Renal and Transplant Associates, Springfield, Massachusetts, United States
University of Cincinnati, Cincinnati, Ohio, United States
Northeast Clinical Research, Allentown, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
Southwest Houston Research Ltd., Houston, Texas, United States
Contact Details
Name: Joel Melnick, MD
Affiliation: OPKO Renal
Role: STUDY_DIRECTOR
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