This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Single dose oral administration
single IV injection
Pivotal Research Centers
Peoria, Arizona, United States
Research by Design
Evergreen Park, Illinois, United States
Western New England Renal & Transplant Associates
Springfield, Massachusetts, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States
DCI
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Northeast Clinical Research
Allentown, Pennsylvania, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Southwest Houston Research Ltd
Houston, Texas, United States
...and 2 more locations
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
Time frame: from 3 to 0 hours prior to dosing until 42 days post dosing
To assess the safety and tolerability of CTAP101 capsules and injection
Time frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
Time frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
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