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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Comparison of different dose strengths of CTAP201 after single dose.
Comparison of different dose strengths of doxercalciferol after single dose.
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
Blood levels of CTAP201 and doxercalciferol
Time frame: Day 1 and Day 15 of each dose level
Safety of a single dose of CTAP201 Injection
Time frame: Throughout the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.